Data / Medical devices / Accessories, Implant, Dental, Endosseous

Accessories, Implant, Dental, Endosseous (NDP): 451 FDA-registered makers in 36 countries

Name: FDA-registered makers of Accessories, Implant, Dental, Endosseous
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

451 establishments in 36 countries are registered with the FDA to make Accessories, Implant, Dental, Endosseous (product code NDP, Class 1, 21 CFR 872.3980). 3 of them have a 510(k) clearance or PMA approval on file and 10 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on September 2, 2020, and lists 33 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code: NDP
Device class: 1
Regulation: 872.3980
Medical specialty: Dental

Makers by country

Country	Makers
United States	107
China	70
South Korea	66
Germany	51
Israel	27
Switzerland	20
Pakistan	14
Italy	11
Taiwan	10
Spain	10
France	8
Brazil	8
India	8
Sweden	7
Canada	3
Japan	3
Hong Kong	3
Turkey	2
Australia	2
Denmark	2
United Kingdom	2
Costa Rica	2
Austria	2
Belgium	1
Poland	1
Vietnam	1
Ireland	1
Liechtenstein	1
Portugal	1
Colombia	1
Hungary	1
Mexico	1
Andorra	1
South Africa	1
Netherlands	1
Cyprus	1

Makers of Accessories, Implant, Dental, Endosseous

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	510(k) clearances	Latest clearance	Recall events	Source
DENTSPLY Implants N.V.	Hasselt Limburg, Belgium	Manufacturer, Specification developer	1	September 2, 2020	0	api.fda.gov
Sirona Dental Systems GMBH	BENSHEIM Hesse, Germany	Manufacturer, Specification developer	1	September 27, 2019	0	api.fda.gov
Thommen Medical, AG	GRENCHEN Solothurn, Switzerland	Manufacturer	1	April 17, 2007	2	api.fda.gov
35newtons, LLC	Tacoma, WA, United States	Specification developer	0		0	api.fda.gov
3bfab Teknoloji Anonim Sirketi	Istanbul, Turkey	Manufacturer	0		0	api.fda.gov
3D Diagnostix Inc	Allston, MA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
3diemme SRL	Cantu Como, Italy	Manufacturer	0		0	api.fda.gov
5 Axis Dental Inc.	Whitby Ontario, Canada	Manufacturer	0		0	api.fda.gov
A. Schweickhardt GMBH & Co. KG	Seitingen-Oberflacht Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
A.B. Dental Devices Ltd	Ashdod Southern, Israel	Manufacturer	0		0	api.fda.gov
Abracadabra Implants Ltd.	Or Yehuda Central, Israel	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Accompany Surgical	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Accumedix, Inc.	Libertyville, IL, United States	Contract manufacturer	0		0	api.fda.gov
ACH Medical Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Acheron Instruments (pvt.) Ltd.	LAHORE Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Adin Dental Implant Systems Ltd.	Afula Northern, Israel	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Advantech Plastics, LLC	Woodstock, IL, United States	Contract manufacturer	0		0	api.fda.gov
Aidite (qinhuangdao) Technology Co., Ltd	Qinhuangdao City Hebei, China	Manufacturer	0		0	api.fda.gov
Albensi Dental Lab	Irwin, PA, United States	Manufacturer	0		0	api.fda.gov
Alliance Global Technology Co., Ltd.	Kaohsiung, Taiwan	Manufacturer	0		0	api.fda.gov
Alliedstar Medical Equipment Co., Ltd.	Ziyang Sichuan, China	Manufacturer	0		0	api.fda.gov
Allonus Tech Co., Ltd.	Yangsan-si Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Alpha Dent Implants GMBH	Pforzheim Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Alpha-Bio Tec	Modi'in Central, Israel	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Altatec GMBH	WIMSHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Amedcon Medical Technology (shenzhen) Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer	0		0	api.fda.gov
American Dental Implant Corporation	New Castle, PA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Andreas Hettich GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltd	Anqing City Anhui, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Anthogyr	SALLANCHES Haute-Savoie, France	Manufacturer	0		0	api.fda.gov
APOLLO IMPLANT COMPONENTS Sp. z o.o.	Pabianice Lodzkie, Poland	Manufacturer	0		0	api.fda.gov
APPLIED DENTAL INC. DBA AD Surgical	Sunnyvale, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Apply Labwork Inc.	Taoyuan City, Taiwan	Manufacturer	0		0	api.fda.gov
Arch Medical& Aerospace- Minneapolis, LLC	New Hope, MN, United States	Contract manufacturer	0		0	api.fda.gov
ARCH Medical Solutions - Escondido LLC	Escondido, CA, United States	Manufacturer	0		0	api.fda.gov
ARDS Industries Ltd	Petah Tikva Central, Israel	Specification developer	0		0	api.fda.gov
ARUM DENTISTRY Co., Ltd.	Yuseong-gu Daejeon, South Korea	Manufacturer	0		0	api.fda.gov
Asiga	Alexandria New South Wales, Australia	Manufacturer	0		0	api.fda.gov
Atomica Technology, Inc	Atlanta, GA, United States	Manufacturer	0		0	api.fda.gov
ATRIA Co.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Avinent Implant System S.L.U.	Santpedor Barcelona, Spain	Manufacturer	0		0	api.fda.gov
Aceso Dental Laboratory Company Limited	An Phuoc Ward Dong Nai, Vietnam	Manufacturer	0		0	api.fda.gov
Aidite (Shenzhen) Medical Technology Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer	0		0	api.fda.gov
B&L Biotech Co., Inc	Ansan City Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
B. Ali Impex	SIALKOT, Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
B.T.I. Biotechnology Institute, S.L.	Miñano Alava, Spain	Exporter to the US, Manufacturer, Specification developer	0		0	api.fda.gov
Baechler Feintech AG	Hoelstein Basel-Landschaft, Switzerland	Contract manufacturer	0		0	api.fda.gov
Bego Implant Systems GMBH & Co. KG	Bremen, Germany	Manufacturer	0		0	api.fda.gov
Beijing Yingguan Dental Science&technology Co.,ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
BHI Implants	Afula Northern, Israel	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Bicon, LLC	Boston, MA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Bio Concept Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Biodenta Swiss AG	Berneck Sankt Gallen, Switzerland	Specification developer	0		0	api.fda.gov
Biohorizons Implant Systems Inc.	Birmingham, AL, United States	Manufacturer	0		1	api.fda.gov
Bioline Dental Implant Systems Ltd	Migdal Tefen Northern, Israel	Manufacturer	0		0	api.fda.gov
Biomaterials Korea Inc.	Hanam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Biotech Dental SAS	Salon de Provence Bouches-du-Rhone, France	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Biotem Co., Ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
Blue Elephant Inc	Whittier, CA, United States	Specification developer	0		0	api.fda.gov
Blue Sky Bio, LLC	Libertyville, IL, United States	Specification developer	0		0	api.fda.gov
BLZ Technology (wuhan) Co., Ltd.	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0		0	api.fda.gov
Bomei Co., Ltd.	Taoyuan City, Taiwan	Manufacturer	0		0	api.fda.gov
Brasseler U.S.A. Dental, LLC	Savannah, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Basic Dental Implant Systems, Inc.	Rio Rancho, NM, United States	Manufacturer	0		0	api.fda.gov
CAMLOG Biotechnologies GmbH	Basel Basel-Stadt, Switzerland	Exporter to the US, Specification developer	0		0	api.fda.gov
Carmex - Precision Tools Ltd.	Maalot Northern, Israel	Contract manufacturer, Manufacturer	0		0	api.fda.gov
CDM Center Of Excellence Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Cendres+metaux SA	Biel/Bienne Bern, Switzerland	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Ceraroot S.L.	Les Franqueses del Valles Barcelona, Spain	Exporter to the US, Manufacturer, Specification developer	0		0	api.fda.gov
Changzhou Sifary Medical Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
Chengdu Besmile Medical Technology Co., Ltd.	Chengdu Sichuan, China	Manufacturer	0		0	api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.	Luzhu District Taoyuan, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Coltene/Whaledent Inc.	Cuyahoga Falls, OH, United States	Manufacturer	0		0	api.fda.gov
Comfort Surgical Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Coremedtech Aps	Allerod Hovedstaden, Denmark	Manufacturer	0		0	api.fda.gov
Cortex Dental Implants Industries Ltd.	Shlomi Northern, Israel	Manufacturer	0		0	api.fda.gov
Covision Co., Ltd.	Incheon, South Korea	Manufacturer	0		0	api.fda.gov
Cowellmedi Co., Ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
CPM Precision GMBH	Hirschberg Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
CSM Implant	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
CeramTec Schweiz GmbH	Spreitenbach Aargau, Switzerland	Manufacturer	0		0	api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.	Changsha Hunan, China	Manufacturer	0		0	api.fda.gov
Cislak Manufacturing, Inc.	Niles, IL, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Cybermed Inc.	Daejeon, South Korea	Manufacturer	0		0	api.fda.gov
D.A.N.D Metal Industries North Ltd	migdal tefen, P.O.B 51 Northern, Israel	Manufacturer	0		0	api.fda.gov
D.S.P. Industrial Eireli Epp	Campo Largo Parana, Brazil	Manufacturer	0		0	api.fda.gov
Dantech Digital Dental Solutions Private Limited	Chennai Tamil Nadu, India	Manufacturer	0		0	api.fda.gov
Davis Dental Lab	Wyoming, MI, United States	Manufacturer	0		0	api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.	Shijiazhuang Hebei, China	Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Degudent GMBH	HANAU Hesse, Germany	Contract manufacturer	0		0	api.fda.gov
Deltamed GMBH	FRIEDBERG Hesse, Germany	Manufacturer	0		0	api.fda.gov
Den Tag S.R.L.	MANIAGO, PN. Pordenone, Italy	Manufacturer	0		0	api.fda.gov
Denq Co., Ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
Denta Craft Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Dental Crafters	Marshfield, WI, United States	Manufacturer	0		0	api.fda.gov
Dental Studio	Anyang-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Dental Wings GMBH	Chemnitz Saxony, Germany	Specification developer	0		0	api.fda.gov
Dentatus AB	SPANGA Stockholm, Sweden	Manufacturer	0		0	api.fda.gov
Dentech Corp.	Tokyo, Japan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Dentin Implants Technologies Ltd.	Mizpe Aviv Northern, Israel	Manufacturer	0		0	api.fda.gov
Dentis Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Dentium Co., Ltd.	Suwon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Dentona AG	Dortmund North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
DENTSPLY IH Inc.	Waltham, MA, United States	Contract manufacturer, Manufacturer	0		1	api.fda.gov
Detax GMBH	ETTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Devemed GMBH	NEUHAUSEN OB ECK Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Digital Arches Inc.	Fountain Valley, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Digital Dental Depot	zhuhai Guangdong, China	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Digital Dental Depot Limited	Hong Kong, Hong Kong	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
DIMPLO Ltd.	Yeonje-gu Busan, South Korea	Manufacturer	0		0	api.fda.gov
DIO Corporation	Haeundae-gu Busan, South Korea	Manufacturer	0		0	api.fda.gov
Ditron Dental Ltd	Ashkelon Southern, Israel	Contract manufacturer, Manufacturer	0		0	api.fda.gov
DMG Digital Enterprises Se	Hamburg, Germany	Manufacturer	0		0	api.fda.gov
Dmi Technology LLC	Lynbrook, NY, United States	Specification developer	0		0	api.fda.gov
DMS Co., Ltd.	Wonju-si Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
Dof Inc	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Dreve America Corp.	Eden Prairie, MN, United States	Manufacturer	0		0	api.fda.gov
Dreve Dentamid GMBH	UNNA North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Dsi Dental Solutions Ltd	Ashdod Southern, Israel	Manufacturer	0		0	api.fda.gov
Dti Implant Systems	Kocaeli, Turkey	Manufacturer	0		0	api.fda.gov
DTS Digital Dental Lab	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Dental Direkt GmbH	Spenge North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Dentauspex Corporation	Douliu Yunlin, Taiwan	Contract manufacturer	0		0	api.fda.gov
Dentis Co.,Ltd	Dong-gu Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Dentsply IH AB	MOLNDAL Vastra Gotaland, Sweden	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Dentsply Implants Manufacturing GmbH	Hanau Hesse, Germany	Contract manufacturer	0		0	api.fda.gov
Eclectic Inc.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Edental Lab Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Elegant Direct Corp	Brooklyn, NY, United States	Manufacturer	0		0	api.fda.gov
Elos Medtech Pinol A/S	Goerloese Hovedstaden, Denmark	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Elos Medtech Timmersdala AB	TIMMERSDALA Vastra Gotaland, Sweden	Contract manufacturer	0		0	api.fda.gov
Emerald Instruments	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Emery Enterprises Inc.	Irvine, CA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Endonest Medical Systems LLP	PALGHAR Maharashtra, India	Manufacturer	0		0	api.fda.gov
Enlighten Materials Co., Ltd.	Taipei City, Taiwan	Specification developer	0		0	api.fda.gov
Eurofins Inpac Medizintechnik GMBH	Birkenfeld Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Euroteknika	SALLANCHES Haute-Savoie, France	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Excellent Precision Technology (dongguan) Co., Ltd	Dongguan Guangdong, China	Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Evidence Implant Inc.	Daegu, South Korea	Contract manufacturer, Manufacturer	0		0	api.fda.gov
FFDM Tivoly	BOURGES CEDEX Centre-Val de Loire, France	Contract manufacturer	0		0	api.fda.gov
Foo Tian Dental Laboratory	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Forum Engineering Technologies (96) Ltd.	Ashkelon Southern, Israel	Manufacturer	0		0	api.fda.gov
Foshan Coxo Medical Instrument Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		0	api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltd	ZHUHAI Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Full Arch Technologies Ltd	Bury St Edmunds Suffolk, United Kingdom	Manufacturer	0		0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Faulhaber Pinzetten KG	FRITTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Formlabs Inc.	Somerville, MA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Formlabs Ohio, Inc.	Millbury, OH, United States	Manufacturer	0		0	api.fda.gov
Gebr. Brasseler GMBH & Co. KG	LEMGO North Rhine-Westphalia, Germany	Contract manufacturer	0		0	api.fda.gov
GENOSS Co., Ltd.	Suwon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Geomedi Co., Ltd.	Uiwang-si, Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Ghousia Amanat Surgical	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Gmi Dental Implantology, S.L.	Lleida Lerida, Spain	Manufacturer	0		0	api.fda.gov
Green Dental Lab	Heber Springs, AR, United States	Manufacturer	0		0	api.fda.gov
Guangdong Zhilianxing Precision Technology Co.,ltd.	Shantou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangxi Ehall Medical Technology Co.,ltd	Nanning Guangxi, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Guangzhou Heygears Imc.inc	Guangzhou Guangdong, China	Specification developer	0		0	api.fda.gov
Guided Smile	Independence, OH, United States	Manufacturer, Specification developer	0		0	api.fda.gov
GUILIN YIKESHI Medical Device CO LTD	Guilin Guangxi, China	Manufacturer	0		0	api.fda.gov
Gunter Medical GMBH	Pforzheim Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Graphy Inc.	Seoul, South Korea	Exporter to the US, Manufacturer	0		0	api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.	GUANGZHOU Guangdong, China	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
H & H Co.	Hayden, ID, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
HADER Solutions & Distribution Ltd	Swords CO Dublin Dublin(County), Ireland	Manufacturer	0		0	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Shining3d Dental Technology Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Westlake Biomaterial Co., Ltd.	Hangzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Hebumedical GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Hefei Mlush Sanitary Products Co.,ltd	Hefei Anhui, China	Manufacturer	0		0	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hi Tec Implants, Ltd.	HERZLIA Tel Aviv, Israel	Manufacturer	0		0	api.fda.gov
Hiossen Inc.	Fairless Hills, PA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Hiossen, Inc.	Morrisville, PA, United States	Manufacturer	0		0	api.fda.gov
Hongkong DS Dental Technology Co. Limited	Tung Chung Lantau, Hong Kong	Manufacturer	0		0	api.fda.gov
Hospimed MFG	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Huanghua Promisee Dental Co., Ltd	Huanghua Hebei, China	Manufacturer	0		0	api.fda.gov
Hub Biotech Co., Ltd.	BUCHEON-SI Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Humeditech Co., Ltd	Gimhae-si Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Hung Chun Bio-S Co., Ltd.	Kaohsiung City, Taiwan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Iditec North West S.L.	TORRELODONES Madrid(Autonomous Community), Spain	Manufacturer	0		0	api.fda.gov
Idoc Dental Lab	Orange, CA, United States	Contract manufacturer	0		0	api.fda.gov
Ids Korea	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Implacil De Bortoli Material Odontologico Ltda	Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Implant Concierge	San Antonio, TX, United States	Manufacturer	0		0	api.fda.gov
Implant Direct Sybron Manufacturing LLC	Thousand Oaks, CA, United States	Manufacturer, Repackager or relabeler	0		4	api.fda.gov
Implant Protesis Dental 2004, S.L.	Premia de Dalt Barcelona, Spain	Manufacturer	0		0	api.fda.gov
Implant Solutions Pty Ltd (trading AS Osteon Medical)	Mulgrave Victoria, Australia	Manufacturer	0		0	api.fda.gov
Improve Co.,limited	Lantau Island Hong Kong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Infinetamed AG	Sarnen Obwalden, Switzerland	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Infinitum Eta Ltd.	Petach Tikva Central, Israel	Contract manufacturer	0		0	api.fda.gov
Innobiosurg Co., Ltd.	Daejeon, South Korea	Manufacturer	0		0	api.fda.gov
Innovaid Co.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Innovation Meditech GMBH	UNNA North Rhine-Westphalia, Germany	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Institut Straumann AG	BASEL Basel-Stadt, Switzerland	Specification developer	0		0	api.fda.gov
Intai Technology Corp. Implants Business Unit	Taichung City, Taiwan	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Iq Implants Ltd	Omer Southern, Israel	Manufacturer, Specification developer	0		0	api.fda.gov
Ivoclar Vivadent AG	Schaan, Liechtenstein	Manufacturer, Specification developer	0		0	api.fda.gov
Izenimplant Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Izenimplant Co., Ltd.	Pyeongtaek-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Implant Logistics / AMS Micromedical	Sparta, WI, United States	Complaint file establishment, Contract manufacturer, Manufacturer	0		0	api.fda.gov
Ivoclar Vivadent Manufacturing GmbH	NATURNO (BZ) Bolzano, Italy	Contract manufacturer	0		0	api.fda.gov
J & J Instruments, LLC	Northbrook, IL, United States	Specification developer	0		0	api.fda.gov
J Dental Care SRL	Modena, Italy	Manufacturer	0		0	api.fda.gov
Jeil Medical Corporation	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Jiangxi Heygears Innovative Material Co., Ltd	Jiujiang Jiangxi, China	Contract manufacturer	0		0	api.fda.gov
Jiangyin Nanquan Macromolecule Product Co., Ltd.	JIANGYIN Jiangsu, China	Manufacturer	0		0	api.fda.gov
JINTAIK (Yunnan) BIOTECH CO., LTD.	Kunming Yunnan, China	Manufacturer	0		0	api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SA	Curitiba Parana, Brazil	Manufacturer	0		0	api.fda.gov
Josef Ganter Feinmechanik GMBH	DAUCHINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Kaiser Precision Co.	Hwaseong Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Kamal Encon Industries Limited	Faridabad Haryana, India	Manufacturer	0		0	api.fda.gov
Kaul Medizintechnik GMBH	Dierdorf Rhineland-Palatinate, Germany	Manufacturer	0		0	api.fda.gov
KJ Meditech Co., Ltd.	Gwangju, South Korea	Contract sterilizer, Manufacturer	0		0	api.fda.gov
KLS Martin Se & Co. KG	Fridingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS Martin SE & Co. KG	Muhlheim/Donau Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS-Martin L.P.	Jacksonville, FL, United States	Specification developer	0		0	api.fda.gov
KTJ Dental Lab Inc	Los Angeles, CA, United States	Manufacturer	0		0	api.fda.gov
KTJ Medical Technology Co.,Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Keystone Industries	Myerstown, PA, United States	Manufacturer	0		0	api.fda.gov
Keystone Industries	Cherry Hill, NJ, United States	Manufacturer	0		0	api.fda.gov
Keystone Industries - Gibbstown	Gibbstown, NJ, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Kohler Medizintechnik GmbH	STOCKACH Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
La Precision Industry	SCIONZIER Haute-Savoie, France	Contract manufacturer	0		0	api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.	Cartago, Costa Rica	Manufacturer	0		0	api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer	0		0	api.fda.gov
Libral Traders Pvt. Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
LISI MEDICAL Remmele	Coon Rapids, MN, United States	Contract manufacturer	0		0	api.fda.gov
LX Precision Portugal, Unipessoal, Lda	Castelo de Paiva Aveiro, Portugal	Contract manufacturer	0		0	api.fda.gov
LX Precision Shanghai Co Ltd	Shanghai, China	Contract manufacturer	0		0	api.fda.gov
Loyol New Material Suhzou Co.,Ltd.	Suzhou Jiangsu, China	Manufacturer	0		0	api.fda.gov
M/S Leixir Resources Pvt. Ltd	GURUGRAM Haryana, India	Manufacturer	0		0	api.fda.gov
Maillefer Instruments Holding Sarl	BALLAIGUES Vaud, Switzerland	Contract manufacturer	0		0	api.fda.gov
Manix Co., Ltd.	Anseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Maquira Industria De Produtos Odontologicos	Maringa Parana, Brazil	Manufacturer	0		0	api.fda.gov
Mctbio	Yongin-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Mectron S.P.A.	CARASCO Genova, Italy	Manufacturer	0		0	api.fda.gov
Medentika GMBH	Huegelsheim Baden-Wurttemberg, Germany	Specification developer	0		0	api.fda.gov
MEDESY srl	MANIAGO Pordenone, Italy	Manufacturer	0		0	api.fda.gov
Medical Systems And Devices International Ltd.	Kiryat Ata Haifa, Israel	Manufacturer	0		0	api.fda.gov
Mediclus Co., Ltd	Cheongju-si Chungbuk, South Korea	Manufacturer	0		0	api.fda.gov
Medicon, E.G.	TUTTLINGEN Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Medihub Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Medimecca Co Ltd	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Microware Precision Co., Ltd.	Taichung, Taiwan	Contract manufacturer	0		0	api.fda.gov
MIS Implants Technologies Ltd.	BAR LEV INDUSTRIAL PARK Northern, Israel	Manufacturer	0		0	api.fda.gov
MK Meditech	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.	SAO CARLOS Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Modern Dental Laboratory Usa, LLC	Alpharetta, GA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Mozo-Grau SA	Valladolid, Spain	Exporter to the US, Manufacturer	0		0	api.fda.gov
Medentika GmbH	Calw Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)	Daegu, South Korea	Specification developer	0		0	api.fda.gov
Megagen Implant Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Microdental Laboratories	Livermore, CA, United States	Contract manufacturer	0		0	api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Nakanishi Inc.	Kanuma Tochigi, Japan	Manufacturer	0		0	api.fda.gov
Natural Esthetics	Fuessen Bavaria, Germany	Manufacturer	0		0	api.fda.gov
NDX nSequence	Reno, NV, United States	Manufacturer	0		0	api.fda.gov
Neobiotech Co., Ltd.	Wonju-si Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
Neoss AB	Goteborg Vastra Gotaland, Sweden	Manufacturer	0		0	api.fda.gov
New Perfect Dental Lab	SHENZHEN Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
New Stetic	GUARNE Antioquia, Colombia	Manufacturer	0		0	api.fda.gov
Newton Implant Systems	Vista, CA, United States	Specification developer	0		0	api.fda.gov
Nextcon International	Sialkot Punjab, Pakistan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Nichrominox	SAINT BONNET DE MURE Rhone, France	Contract manufacturer	0		0	api.fda.gov
Ningbo Sezen Technology Co., Ltd.	Ningbo Zhejiang, China	Contract manufacturer	0		0	api.fda.gov
Nobel Biocare AB	GOTEBORG Vastra Gotaland, Sweden	Specification developer	0		0	api.fda.gov
Nobel Biocare AB, Produktion	KARLSKOGA Orebro, Sweden	Contract manufacturer	0		0	api.fda.gov
Nobel Biocare Procera, LLC	Mahwah, NJ, United States	Complaint file establishment, Contract manufacturer	0		0	api.fda.gov
Nobel Biocare Usa, LLC	Yorba Linda, CA, United States	Contract manufacturer	0		2	api.fda.gov
Nobil-Metal S P A	Villafranca Dasti, Italy	Manufacturer	0		0	api.fda.gov
Noris Medical Ltd.	Nesher Haifa, Israel	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Northwell Health	Manhasset, NY, United States	Manufacturer	0		0	api.fda.gov
Nova Implants Ltd	Or-Yehuda Tel Aviv, Israel	Specification developer	0		0	api.fda.gov
Nobel Biocare Services AG	Kloten Zurich, Switzerland	Specification developer	0		0	api.fda.gov
Oco Biomedical	Albuquerque, NM, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ods Co., Ltd.	Incheon, South Korea	Manufacturer	0		0	api.fda.gov
One Day Dental Partner	Suncheon-si Jeonnam, South Korea	Exporter to the US, Manufacturer	0		0	api.fda.gov
Onvet Medical Canada Inc	TORONTO Ontario, Canada	Manufacturer	0		0	api.fda.gov
Open Implants	Santa Ana, CA, United States	Manufacturer	0		0	api.fda.gov
Orangecad Med GMBH	Karlsruhe Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Orchid Unique	Bridgeport, MI, United States	Contract manufacturer	0		0	api.fda.gov
Osseo Pure Inc	Lancaster, NY, United States	Manufacturer	0		0	api.fda.gov
Osstem Implant Co., Ltd.	Gangseo-gu Seoul, South Korea	Specification developer	0		0	api.fda.gov
Osstem Implant Co., Ltd.	Haeundae-gu Busan, South Korea	Manufacturer	0		0	api.fda.gov
Ossvis Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Osung MND Co., Ltd.	Gimpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Ot Medical GMBH	Bremen, Germany	Manufacturer	0		0	api.fda.gov
Oneday Biotech Co., Ltd.	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Palaxa Precision LLC	Newport, MN, United States	Specification developer	0		0	api.fda.gov
Paltop Advanced Dental Solutions Ltd	Caesarea Central, Israel	Contract manufacturer, Manufacturer	0		1	api.fda.gov
Panorama International.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Panthera Dental Inc	Quebec City, Canada	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Paragon Implant Company, LLC	Las Vegas, NV, United States	Manufacturer	0		0	api.fda.gov
Paragon Implant MFG., LLC	Calabasas, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Paragon Medical, Inc.	Pierceton, IN, United States	Contract manufacturer	0		0	api.fda.gov
Part Precision Sweden AB	Mariestad Vastra Gotaland, Sweden	Contract manufacturer	0		0	api.fda.gov
Pengbo (shenzhen) Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Phen'x Technologies	Chassieu Auvergne-Rhone-Alpes, France	Contract manufacturer	0		0	api.fda.gov
PNUAdd Co., Ltd.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
POINTIMPLANT Co., Ltd	Busan, South Korea	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Practicon, Inc.	Greenville, NC, United States	Manufacturer	0		0	api.fda.gov
PREAT Corporation	Santa Maria, CA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		1	api.fda.gov
Precision One Medical	Oceanside, CA, United States	Contract manufacturer	0		0	api.fda.gov
Preferred Oral Design Limitada	Alajuela, San Rafael, Costa Rica	Contract manufacturer	0		0	api.fda.gov
Prevest Denpro Limited	Jammu Jammu and Kashmir, India	Manufacturer	0		0	api.fda.gov
Prime Dental Manufacturing, Inc.	Chicago, IL, United States	Manufacturer	0		0	api.fda.gov
Prismatik Dentalcraft, Inc.	Irvine, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		1	api.fda.gov
Pro3dure Medical GMBH	Iserlohn North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
PSM Medical GmbH	Gunningen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Puracon GMBH	Rosenheim Bavaria, Germany	Contract manufacturer	0		0	api.fda.gov
Park Dental Research Corp	Ardmore, OK, United States	Manufacturer	0		0	api.fda.gov
Precision One Medical	Hoover, AL, United States	Contract manufacturer	0		0	api.fda.gov
Primo Medical Group, INC	Stoughton, MA, United States	Contract manufacturer	0		0	api.fda.gov
Quality Tech Services, LLC	Bloomington, MN, United States	Contract manufacturer	0		0	api.fda.gov
Quickdent Devices Private Limited	Mumbai Maharashtra, India	Specification developer	0		0	api.fda.gov
Ray Co., Ltd	Yongin-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
RDJ Tov Implant Ltd	Jerusalem, Israel	Specification developer	0		0	api.fda.gov
Reliable Dental Studio, Inc.	Rosemead, CA, United States	Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Reoss GMBH	Filderstadt Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Rex Implants, Inc	Columbus, OH, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Rhein 83 SRL	BOLOGNA Emilia-Romagna, Italy	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Riellens Industria E Comercio Ltda	Vargem Grande Paulista Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
RODO Digital Prosthetics	Troy, MI, United States	Contract manufacturer	0		0	api.fda.gov
Rodo Medical, Inc	Troy, MI, United States	Manufacturer	0		0	api.fda.gov
RP Conexoes Restauradoras Ltda	Caieiras Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Ruetschi Technology SA	Yverdon-les-Bains Vaud, Switzerland	Contract manufacturer	0		0	api.fda.gov
Riton 3D Technology Co., Ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Ritter Implants GmbH & Co. KG	Biberach Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
S.G.S. International Ltd	Budapest, Hungary	Manufacturer	0		0	api.fda.gov
S.I.N. Implant System Ltda	Sao Paulo, Brazil	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Samaplast AG	Sankt Margrethen Sankt Gallen, Switzerland	Contract manufacturer	0		0	api.fda.gov
Sculpture Studios	Cary, NC, United States	Manufacturer	0		0	api.fda.gov
SDS Swiss Dental Solutions	Kreuzlingen Thurgau, Switzerland	Specification developer	0		0	api.fda.gov
SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Sentronic International Corp.	Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
Sewon Medix, Inc.	Busan, South Korea	Manufacturer	0		0	api.fda.gov
Shandong Hengfeng Kerui Medical Equipment Co., Ltd	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., Ltd	Heze Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Lions Industrial Co.,ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shenzhen Dazhou Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen Hetailai Technology Co.,ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen HLD Dental&technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Yongchanghe Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shinsaegi Medi-Tech Co., Ltd.	Gimhae-si Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Sic Invent AG	Basel Town Basel-Landschaft, Switzerland	Exporter to the US, Manufacturer	0		0	api.fda.gov
Sicat GMBH & Co. KG	BONN North Rhine-Westphalia, Germany	Exporter to the US, Manufacturer	0		0	api.fda.gov
SKY DENTAL LAB (International)	Zhuhai Guangdong, China	Manufacturer	0		0	api.fda.gov
Sky HKMC International Limited	Hong Kong, Hong Kong	Exporter to the US, Manufacturer	0		0	api.fda.gov
Smart Denture Conversions, LLC	Apex, NC, United States	Manufacturer, Specification developer	0		0	api.fda.gov
SMD Dental Laboratory	Heungdeok-gu Cheongju-si Chungbuk, South Korea	Contract manufacturer	0		0	api.fda.gov
Smile Line SA	St-Imier Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Snucone Co., Ltd.	Dalseo-gu Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Soadco, S.L.	Escaldes-Engordany, Andorra	Manufacturer	0		0	api.fda.gov
Solventum Us LLC	Eagan, MN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Southern Implants (pty) Ltd	IRENE Gauteng, South Africa	Manufacturer	0		0	api.fda.gov
Sprintray Inc.	Los Angeles, CA, United States	Manufacturer	0		0	api.fda.gov
Sprintray Inc.	Huntington Beach, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Steco-System-Technik GMBH & Co. KG	Hamburg, Germany	Manufacturer	0		0	api.fda.gov
Storz Am Mark GMBH	EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Stratasys Ltd	Kiryat Gat Southern, Israel	Manufacturer	0		0	api.fda.gov
STRATASYS LTD - Headquarter	Rehovot Central, Israel	Complaint file establishment, Specification developer	0		0	api.fda.gov
Stryker Leibinger GMBH & Co. KG	FREIBURG Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Suncoast Dental, Inc.	Clearwater, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Superior Machined Products, Inc.	Oceanside, CA, United States	Contract manufacturer	0		0	api.fda.gov
Surcam Medical Devices And Developments Ltd	Nahariya Northern, Israel	Manufacturer	0		0	api.fda.gov
Surgicrafts	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Surgident Co., Ltd.	Dong-gu Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Surgikor, LLC	Los Angeles, CA, United States	Specification developer	0		0	api.fda.gov
Suzhou Laixin 3D Technology Co.,ltd	Suzhou Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Sweden & Martina S.P.A.	Due Carrare Padova, Italy	Manufacturer	0		0	api.fda.gov
Symmetry Medical Polyvac SAS	WAMBRECHIES Nord, France	Contract manufacturer	0		0	api.fda.gov
Shandong Huge Dental Material Corporation	Rizhao Shandong, China	Manufacturer	0		0	api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shinhung MST Co., Ltd.	Wonju Si Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
Shining 3D Tech Co.,Ltd.	Hangzhou Zhejiang, China	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sirona Dental Systems GmbH	Bensheim Hesse, Germany	Specification developer	0		0	api.fda.gov
Smyles Above Innovations, Inc	Barrington, IL, United States	Contract manufacturer, Specification developer	0		0	api.fda.gov
Solventum US LLC	San Antonio, TX, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Sterngold Dental LLC	Attleboro, MA, United States	Manufacturer	0		0	api.fda.gov
Straumann Manufacturing, Inc.	Mansfield, TX, United States	Manufacturer	0		0	api.fda.gov
Straumann Manufacturing, Inc.	Andover, MA, United States	Manufacturer	0		0	api.fda.gov
Straumann Villeret SA	VILLERET Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Straumann Villeret SA	Corgemont Bern, Switzerland	Manufacturer	0		0	api.fda.gov
T. Strong Inc.	Gimhae-si Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Talladium Espana, SL	LLEIDA Lerida, Spain	Manufacturer	0		0	api.fda.gov
Terrats Medical, S.L.	Barbera del Valles Barcelona, Spain	Contract manufacturer, Manufacturer	0		0	api.fda.gov
TF New Material Sci And Tec Co.,ltd	Huainan Anhui, China	Manufacturer	0		0	api.fda.gov
Titan Implants, Inc.	Bergenfield, NJ, United States	Manufacturer	0		0	api.fda.gov
Track Of Surgical	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Tri Dental Implants Int. AG	Huenenberg Zug, Switzerland	Manufacturer	0		0	api.fda.gov
Troy Innovative Instruments Co LLC	Middlefield, OH, United States	Contract manufacturer	0		0	api.fda.gov
Truabutment Inc.	Irvine, CA, United States	Manufacturer	0		1	api.fda.gov
The American Angle, LLC	Brooklyn, NY, United States	Contract manufacturer, Specification developer	0		0	api.fda.gov
The Argen Corporation	San Diego, CA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
The Belport Company, Inc DBA Gingi-Pak	Camarillo, CA, United States	Manufacturer	0		0	api.fda.gov
Theia Holding SA	La Chaux-de-Fonds Neuchatel, Switzerland	Contract manufacturer	0		0	api.fda.gov
TruAbutment Korea Co., Ltd.	Bucheon-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Uniqa Dental Ltd	Netanya Central, Israel	Manufacturer	0		0	api.fda.gov
United Laboratories Corporation	Tukwila, WA, United States	Manufacturer	0		0	api.fda.gov
Vericom Co., Ltd.	Chuncheon-Si Gangwon, South Korea	Manufacturer	0		0	api.fda.gov
Versah LLC	Jackson, MI, United States	Manufacturer	0		0	api.fda.gov
Versah, LLC	Jackson, MI, United States	Manufacturer	0		0	api.fda.gov
Vertex-Dental B.V.	Soesterberg Utrecht, Netherlands	Manufacturer	0		0	api.fda.gov
Vico Dental Technology Co. Ltd	DongGuan City Guangdong, China	Manufacturer	0		0	api.fda.gov
VP Innovato Holdings Ltd	Aradippou Larnaka, Cyprus	Manufacturer	0		0	api.fda.gov
Vulcan Custom Dental	Hoover, AL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Vedia Solutions, Division of Laxmi Dental Limited	Palghar Maharashtra, India	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
W&H Dentalwerk Buermoos GMBH	BUERMOOS Salzburg, Austria	Contract manufacturer	0		0	api.fda.gov
W&H Dentalwerk Buermoos GMBH - Site 2	BUERMOOS Salzburg, Austria	Contract manufacturer	0		0	api.fda.gov
WARANTEC Co., Ltd.	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Well Medical	Incheon, South Korea	Manufacturer	0		0	api.fda.gov
Wesley Coe (cambridge) Ltd	ELY, CAMBS Cambridgeshire, United Kingdom	Contract manufacturer	0		0	api.fda.gov
Whip-Mix Corp.	Louisville, KY, United States	Manufacturer	0		0	api.fda.gov
Whitecap Dental Lab And Milling, LLC	American Fork, UT, United States	Contract manufacturer	0		0	api.fda.gov
Xiamen Antinsky Industry Co., Ltd	Xiamen Fujian, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Xiamen Xiang Ji Precision Machinery Technology Co., Ltd	Xiamen Fujian, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Xiamen Yizhou Imp. & Exp. Co., Ltd.	Xiamen Fujian, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Yamahachi Dental MFG. Co.	Gamagori City Aichi, Japan	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Yamahachi Dental Material (Changshu) Co., Ltd.	Changshu city Jiangsu, China	Manufacturer	0		0	api.fda.gov
Z-Systems AG	Oensingen Solothurn, Switzerland	Manufacturer	0		0	api.fda.gov
Zain's Medical Image	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Zentek Medical LLC	Manalapan, NJ, United States	Specification developer	0		0	api.fda.gov
Zeros Co., Ltd.	Gimhae-si Gyeongnam, South Korea	Manufacturer	0		0	api.fda.gov
Zest Anchors, LLC	Carlsbad, CA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Zest Anchors, LLC	Escondido, CA, United States	Manufacturer	0		0	api.fda.gov
Zhongshan Saxin Electric Heating Technology Co., Ltd.	Zhongshan Guangdong, China	Manufacturer	0		0	api.fda.gov
Zhuhai DS Dental Technology Co., Ltd	Zhuhai Guangdong, China	Manufacturer	0		0	api.fda.gov
Zhuhai Meierjing Medical Instrument Co., Ltd.	Zhuhai Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Ziacom Implants Slu	Pinto Madrid(Province), Spain	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Zima International, Inc.	Lehi, UT, United States	Manufacturer	0		0	api.fda.gov
Zirkonzahn SRL	Gais Bolzano, Italy	Manufacturer	0		0	api.fda.gov
Ziyang Freqty Medical Equipment Co., Ltd.	Ziyang Sichuan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Zuga Medical, Inc.	Cleveland, OH, United States	Manufacturer	0		0	api.fda.gov
Zfx GmbH	Dachau Bavaria, Germany	Complaint file establishment, Manufacturer	0		0	api.fda.gov
ZimVie US Corp LLC	Palm Beach Gardens, FL, United States	Manufacturer, Repackager or relabeler, Specification developer	0		6	api.fda.gov
etkon GMBH	Markkleeberg Saxony, Germany	Manufacturer	0		0	api.fda.gov
iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		0	api.fda.gov

Updated September 2, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.