Data / Medical devices / Instruments, Dental Hand

Instruments, Dental Hand (DZN): 281 FDA-registered makers in 24 countries

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

281 establishments in 24 countries are registered with the FDA to make Instruments, Dental Hand (product code DZN, Class 1, 21 CFR 872.4565). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 16 510(k) clearances under this code, the latest on July 25, 2012, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: DZN
Device class: 1
Regulation: 872.4565
Medical specialty: Dental

Makers by country

Country	Makers
United States	79
China	58
Pakistan	47
Germany	38
Italy	7
South Korea	7
Switzerland	6
Israel	6
Brazil	5
Taiwan	5
Japan	4
United Kingdom	3
Sweden	3
Malaysia	2
France	2
Mexico	1
Canada	1
Liechtenstein	1
Costa Rica	1
India	1
Finland	1
New Zealand	1
Denmark	1
Czechia	1

Makers of Instruments, Dental Hand

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
Den-Mat Holdings, LLC	Lompoc, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	1	January 3, 1978	0	api.fda.gov
Dentsply LLC	Milford, DE, United States	Manufacturer, Specification developer	1	August 7, 1980	0	api.fda.gov
Polydentia S.A.	MEZZOVICO-Vira Ticino, Switzerland	Manufacturer, Repackager or relabeler	1	January 17, 1980	0	api.fda.gov
A. Milazzo Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract 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
Acheron Instruments (pvt.) Ltd.	LAHORE Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Acme Enterprises	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Acot Plastics (xiamen) Co., Ltd.	XIAMEN Fujian, China	Contract manufacturer	0		0	api.fda.gov
Addent, Inc.	Danbury, CT, United States	Manufacturer	0		0	api.fda.gov
Adin Dental Implant Systems Ltd.	Afula Northern, Israel	Manufacturer	0		0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Air Water Realize Inc.	IWAKI-SHI Fukushima, Japan	Contract manufacturer	0		0	api.fda.gov
Air Water Realize Inc.	Kasama-shi Ibaraki, Japan	Contract manufacturer	0		0	api.fda.gov
Allure Ortho	Whitinsville, MA, United States	Specification developer	0		0	api.fda.gov
American Eagle Instruments	Missoula, MT, United States	Manufacturer	0		0	api.fda.gov
Andre Gregate Braga Instrumentos Ltda	CAIEIRAS Sao Paulo, Brazil	Foreign private label distributor, 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
Armatech International	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Armm, Inc.	Huntington Beach, CA, United States	Contract manufacturer, Contract sterilizer	0		0	api.fda.gov
Asa Dental S.P.A.	MARLIA Lucca, Italy	Manufacturer	0		0	api.fda.gov
Asanus Medizintechnik GMBH	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Aseptico, Inc.	Woodinville, WA, United States	Manufacturer for export	0		0	api.fda.gov
Ashtel Studios, Inc.	Ontario, CA, United States	Specification developer	0		0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
ATRIA Co.	Seoul, South Korea	Manufacturer	0		0	api.fda.gov
Autocam Medical	Murfreesboro, TN, United States	Contract manufacturer	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. Braun Medical Industries Sdn. Bhd.	PENANG Pulau Pinang, Malaysia	Contract manufacturer	0		0	api.fda.gov
Bashir Jamil & Brothers (pvt.), Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Beijing Smart Technology Co., Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Beijing ZKSK Technology Co., Ltd.	beijing, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
BH Medical Products Co., Ltd	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Bicon, LLC	Boston, MA, United States	Complaint file establishment, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	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	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Berger Surgical Medical Products GmbH	Neuhausen ob Eck Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Bioclear Matrix Systems, LLC	Tacoma, WA, United States	Specification developer	0		0	api.fda.gov
Calibaja Manufacturing, S.A. De C.V.	MEXICALI Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou Hebei, China	Exporter to the US, 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
Centrix, Inc.	Shelton, CT, United States	Contract manufacturer	0		0	api.fda.gov
Choose Surgical Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Chung Song Industrial Co.	YONGIN-SI Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Coltene/Whaledent GMBH & Co. KG	LANGENAU Baden-Wurttemberg, Germany	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
Commic Surgico	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Concise Enterprises	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Confident Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Crown Surgical Corp.	Sialkot Punjab, Pakistan	Exporter to the US, Manufacturer	0		0	api.fda.gov
D B Orthodontics Ltd	WEST YORKSHIRE England, United Kingdom	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Darleys Surgical Co.	Sialkot, Punjab, Pakistan	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
Den Tag S.R.L.	MANIAGO, PN. Pordenone, Italy	Manufacturer	0		0	api.fda.gov
Denjoy Dental Co., Ltd	Changsha city Hunan, China	Manufacturer	0		0	api.fda.gov
Denovo Dental Inc	Baldwin Park, CA, United States	Specification developer	0		0	api.fda.gov
Denta Craft Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Dental Morelli Ltda.	SOROCABA Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Dentatus AB	SPANGA Stockholm, Sweden	Manufacturer	0		0	api.fda.gov
Dentech Corp.	Tokyo, Japan	Manufacturer	0		0	api.fda.gov
DENTSPLY DETREY GmbH	KONSTANZ 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
DIO Corporation	Haeundae-gu Busan, South Korea	Manufacturer	0		0	api.fda.gov
Directa AB	UPPLANDS VAESBY Stockholm, Sweden	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Dockum Research Lab	Irwindale, CA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Dongguan Magenta Medical Equipment Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Dongguan Ouwen Medical Device Technology Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Dongguan Taifeng Sporting Manufactory Co.	DongGuan City Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
DR. Walser Dental G.M.B.H.	RADOLFZELL Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
DSC Dental, LLC	Saint George, UT, United States	Manufacturer	0		0	api.fda.gov
DayOn Daily Chemical Co., Ltd	Yangzhou Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Dentsply Sirona Orthodontics Inc.	Sarasota, FL, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
E. Hahnenkratt GMBH	KOENIGSBACH-STEIN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Elite Dental Lab	Huizhou City Guangdong, China	Manufacturer	0		0	api.fda.gov
Emerald Instruments	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Empire Surgical Instruments Company	Sialkot Punjab, Pakistan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Endo Tech Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Epdent Co., Ltd.	Gimpo-city Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Fetzer Medical GMBH & Co.kg	Tuttlingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Fetzer Surgical, LLC	Scottsdale, AZ, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
FKG Dentaire Sarl	LE CRET-DU-LOCLE Neuchatel, Switzerland	Manufacturer	0		0	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Frasaco GMBH	TETTNANG Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Garish Apparels	Wazirabad Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Garrison Dental Solutions	Spring Lake, MI, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Gavin Biotechnology Co.,ltd	Jinzhong Shanxi, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
GC America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Gebruder Renggli, AG	Schaffhausen, Switzerland	Contract manufacturer	0		0	api.fda.gov
Gestenco International AB	GOTEBORG Vastra Gotaland, Sweden	Manufacturer	0		0	api.fda.gov
Get-Grin Inc	Airmont, NY, United States	Specification developer	0		0	api.fda.gov
Goldman Products, Inc.	Wauconda, IL, United States	Contract manufacturer, Manufacturer, Remanufacturer	0		0	api.fda.gov
Guangxi Ehall Medical Technology Co.,ltd	Nanning Guangxi, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Guilin Woodpecker Medical Instrument Co., Ltd	GUILIN CITY Guangxi, China	Manufacturer	0		0	api.fda.gov
GoldenDent	Roseville, MI, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Guangdong Xinuo Personal Care Products Co., Ltd	Yunfu City Guangdong, China	Manufacturer	0		0	api.fda.gov
H & H Co.	Hayden, ID, United States	Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Hager & Meisinger GMBH	NEUSS North Rhine-Westphalia, Germany	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
Hazel Enterprises	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Hebumedical GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer, 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, Manufacturer	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hespeler Orthodontics Limited	CAMBRIDGE Ontario, Canada	Manufacturer, Specification developer	0		0	api.fda.gov
Hospimed MFG	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Huanghua DK Dental Co., Ltd	HuangHua Hebei, China	Manufacturer	0		0	api.fda.gov
Huanghua Promisee Dental Co., Ltd	Huanghua Hebei, China	Manufacturer	0		0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Huizhou Videya Technology Co., Ltd.	Huizhou Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Henan Lusterdent Medical Instrument Co.,Ltd	Zhengzhou Henan, China	Manufacturer	0		0	api.fda.gov
Hipp Medical AG	Renquishausen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Inter-Med, Inc.	Racine, WI, United States	Manufacturer	0		0	api.fda.gov
Ivoclar Vivadent AG	Schaan, Liechtenstein	Specification developer	0		0	api.fda.gov
Implant Logistics / AMS Micromedical	Sparta, WI, United States	Contract manufacturer	0		0	api.fda.gov
Instrumed International Inc dba Avalign German Specialty Instruments	Schaumburg, IL, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
J & J Instruments, LLC	Northbrook, IL, United States	Specification developer	0		0	api.fda.gov
Jaffrose International	Sialkot Punjab, Pakistan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Janman Precision Industry Co., Ltd.	Taoyuan, Taiwan	Contract manufacturer	0		0	api.fda.gov
Jay-Med	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Jiangsu Province Yangzhou Shuguang Toothbrush Manufactory	YANG ZHOU Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jin Hsiang Ent Co. Ltd	Changhua, Taiwan	Contract manufacturer, 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
JMS Manufacturing, Inc.	Omaha, NE, United States	Contract manufacturer	0		0	api.fda.gov
Jordco, Inc.	Hillsboro, OR, United States	Manufacturer	0		0	api.fda.gov
Karl Hammacher GMBH	SOLINGEN North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Karl Storz Se & Co KG	TUTTLINGEN Baden-Wurttemberg, Germany	Specification developer	0		0	api.fda.gov
Karl Storz Se & Co. KG	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Karl Storz Se & Co. KG	NEUHAUSEN OBECK Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS Martin Se & Co. KG	Fridingen Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
KLS Martin Malaysia Sdn. Bhd.	Simpang Ampat Pulau Pinang, Malaysia	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
Koehrer Medical Engineering GMBH	Neuss North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Kulzer GMBH	HANAU Hesse, Germany	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Kerr Corporation	Orange, CA, United States	Complaint file establishment, Contract manufacturer, Specification developer	0		0	api.fda.gov
Kerr Corporation	Pomona, CA, United States	Contract manufacturer	0		0	api.fda.gov
Kerr Italia, S.r.l.	SCAFATI Salerno, Italy	Manufacturer	0		0	api.fda.gov
Keystone Dental Inc.	Irvine, CA, United States	Manufacturer	0		0	api.fda.gov
Kohler Medizintechnik GmbH	STOCKACH Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.	Cartago, Costa Rica	Manufacturer	0		0	api.fda.gov
Lacigrus International	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Larident S.R.L.	TRIBOGNA Genova, Italy	Manufacturer	0		0	api.fda.gov
Libral Traders Pvt. Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Lm-Instruments OY	PARAINEN Varsinais-Suomi, Finland	Manufacturer	0		0	api.fda.gov
Madina Surgical Works	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Mainstream Medical Devices	Austin, TX, United States	Contract manufacturer	0		0	api.fda.gov
Maryam Trading	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Max Hauser Suddeutsche Chirurgiemechanik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
MC Bio S.R.L.	Lomazzo Como, Italy	Manufacturer	0		0	api.fda.gov
Medcave Private Limited	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
MEDESY srl	MANIAGO Pordenone, Italy	Manufacturer	0		0	api.fda.gov
Medisporex (pvt) Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	0		0	api.fda.gov
Melpex Beauty Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Metro Medical	Sialkot Punjab, Pakistan	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Mian Shahid Corp.	MUZAFFAR PUR, SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Micro Precision Swiss	Santa Ana, CA, United States	Contract manufacturer	0		0	api.fda.gov
Mts Brothers Surgical Instruments	Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Myka Sons & Co	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.	Ningbo City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Noga Medical Products Ltd.	SHLOMI Northern, Israel	Manufacturer	0		0	api.fda.gov
Nordent MFG., Inc.	Elk Grove Village, IL, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Nova Instruments	Berkshire Wokingham, United Kingdom	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Nubird Inc.	Covington, WA, United States	Manufacturer	0		0	api.fda.gov
Oco Biomedical	Albuquerque, NM, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Orthonu, LLC	Rumson, NJ, United States	Manufacturer	0		0	api.fda.gov
Ossvis Co., Ltd.	Anyang-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Otto Leibinger GMBH	MUEHLHEIM Baden-Wurttemberg, Germany	Contract manufacturer, 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
Ortho Solutions LC	Lake Saint Louis, MO, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Paltop Advanced Dental Solutions Ltd	Caesarea Central, Israel	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Panorama International.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
PDT, Inc.	Msla, MT, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Pesitro Healthcare Products Co., Ltd.	Yangzhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Practicon, Inc.	Greenville, NC, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Precxis	Peillonnex Haute-Savoie, France	Contract manufacturer	0		0	api.fda.gov
Premier Dental Products Co.	Plymouth Meeting, PA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Premier Medical	Philadelphia, PA, United States	Contract manufacturer	0		0	api.fda.gov
Premium Plus (dongguan) Limited	Dongguan Guangdong, China	Manufacturer	0		0	api.fda.gov
Prodont-Holliger S.A.S.	OLLIERGUES Puy-de-Dome, France	Manufacturer	0		0	api.fda.gov
Pru-Dent MFG., Inc.	Schaumburg, IL, United States	Contract manufacturer, Manufacturer, Remanufacturer	0		0	api.fda.gov
PUL & Co.	Las Vegas, NV, United States	Specification developer	0		0	api.fda.gov
Pulpdent Corporation	Watertown, MA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Park Dental Research Corp	Ardmore, OK, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Pascal International, Inc.	Bellevue, WA, United States	Manufacturer	0		0	api.fda.gov
Power Dental USA, Inc.	McHenry, IL, United States	Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Qibei Technology Co., Limited	KL Hong Kong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Quality Concept (pvt) Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
RC Consolidated Services, Inc	Rancho Cucamonga, CA, United States	Specification developer	0		0	api.fda.gov
Ready Set Import	Beverly Hills, CA, United States	Specification developer	0		0	api.fda.gov
Rex Implants, Inc	Columbus, OH, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Rhondium Limited	Katikati Bay of Plenty, New Zealand	Manufacturer	0		0	api.fda.gov
RICOmed Manufacturing	Richardson, TX, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Robinson Healthcare Limited	Worksop Nottinghamshire, United Kingdom	Manufacturer	0		0	api.fda.gov
Ronvig Dental MFG. A/S	DAUGAARD Midtjylland, Denmark	Manufacturer	0		0	api.fda.gov
RZ Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Sabra Dental Products	Bohemia, NY, United States	Specification developer	0		0	api.fda.gov
Sabri Industries	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Schobell Industrial Ltda	Rio Claro Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Sentronic International Corp.	Taipei, Taiwan	Manufacturer	0		0	api.fda.gov
SGS Export Intl.	SIALKOT Punjab, Pakistan	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 Richsource Biological Technology Co.,ltd	Jining Shandong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Kangqiao Dental Instruments Factory	Shanghai, 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 Balinda Technology Co.,ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, 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
Shofu Inc.	FUKUINE, HIGASHIYAMA-KU Kyoto, Japan	Manufacturer	0		0	api.fda.gov
Shurcon Manufacturing Company	Jia Shan Zhejiang, China	Manufacturer	0		0	api.fda.gov
Signor Seven International	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Sitec (pvt.) Ltd.	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Smile Line SA	St-Imier Bern, Switzerland	Manufacturer	0		0	api.fda.gov
Solmetex, LLC	Northborough, MA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Solventum Us LLC	Eagan, MN, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Spartech Instruments & Co.	Sialkot, Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Specialty Appliances, LLC	Cumming, GA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Storz Am Mark GMBH	EMMINGEN-LIPTINGEN Baden-Wurttemberg, Germany	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
SUBAN Instruments Germany GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Suncoast Dental, Inc.	Clearwater, FL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Surgident Co., Ltd.	Dong-gu Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Surgikare	SIALKOT Punjab, Pakistan	Exporter to the US, Manufacturer	0		0	api.fda.gov
Surgiscape	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shenzhen Golden Wish Personal Care Co.,Ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US	0		0	api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Solventum Germany GmbH	Kamen North Rhine-Westphalia, Germany	Complaint file establishment, Specification developer	0		0	api.fda.gov
Solventum Germany GmbH	SEEFELD Bavaria, Germany	Complaint file establishment, Specification developer	0		0	api.fda.gov
Solventum Orthodontics Corporation	Monrovia, CA, United States	Complaint file establishment, Repackager or relabeler, 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
Solventum US LLC	Irvine, CA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
SpofaDental a.s.	Jicin, Czechia	Contract manufacturer	0		0	api.fda.gov
Stengelin Medical GmbH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
T.A. Walthem & Company	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
T.A.G. Medical Products Corporation Ltd	GAATON Northern, Israel	Manufacturer	0		0	api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.	Tangshan Hebei, China	Manufacturer	0		0	api.fda.gov
TDV Dental Ltda	POMERODE Santa Catarina, Brazil	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Temrex Corp.	Freeport, NY, United States	Manufacturer	0		0	api.fda.gov
TF New Material Sci And Tec Co.,ltd	Huainan Anhui, China	Manufacturer	0		0	api.fda.gov
Tontarra Medizintechnik GMBH	WURMLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	0		0	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Manufacturer	0		0	api.fda.gov
Tsuen Lee Metals & Plastic Toys Factory	SHEN ZHEN CITY Guangdong, China	Manufacturer	0		0	api.fda.gov
Ustomed Instrumente GMBH & Co. KG	Tuttlingen Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Ultradent Products Inc.	South Jordan, UT, United States	Manufacturer, Repackager or relabeler	0		1	api.fda.gov
Volgo Care International (private) Limited	Sialkot Punjab, Pakistan	Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
W.R. Rayson Co., Inc.	Burgaw, NC, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Washington Surgical International	SIALKOT Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Wise Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
World Class Technology Corporation	Mcminnville, OR, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Wellmed Dental Medical Supply Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Xiantao S&J Protective Products Co., Ltd	Xiantao Hubei, China	Manufacturer	0		0	api.fda.gov
Xinhua Surgical Instrument Co. Ltd.	ZIBO Shandong, China	Manufacturer	0		0	api.fda.gov
Y. Z. Corporation	SIALKOT Punjab, Pakistan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Young Microbrush LLC	Grafton, WI, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Ze Fang Technology Co., Ltd.	Taichung, Taiwan	Manufacturer	0		0	api.fda.gov
Zest Anchors, LLC	Carlsbad, CA, United States	Manufacturer	0		0	api.fda.gov
Zhejiang Headway Medical Equipment Co., Ltd.	Hangzhou City Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.	Yang Jiao Lang Zin'an Town Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhengzhou Huaer Electro-Optics Technology Co., Ltd.	Zhengzhou Henan, China	Manufacturer	0		0	api.fda.gov
Zhermack S.P.A.	BADIA POLESINE (RO) Rovigo, Italy	Manufacturer	0		0	api.fda.gov
Zirc Dental Products, Inc.	Buffalo, MN, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		0	api.fda.gov
medmix China LTD	Shanghai, China	Contract manufacturer	0		0	api.fda.gov
medmix Deutschland GmbH	Kiel Schleswig-Holstein, Germany	Contract manufacturer, Manufacturer	0		0	api.fda.gov
medmix Switzerland AG	Haag Sankt Gallen, Switzerland	Contract manufacturer	0		0	api.fda.gov

Updated July 25, 2012. 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.