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

Abutment, Implant, Dental, Endosseous (NHA): 309 FDA-registered makers in 30 countries

309 establishments in 30 countries are registered with the FDA to make Abutment, Implant, Dental, Endosseous (product code NHA, Class 2, 21 CFR 872.3630). 131 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 716 510(k) clearances under this code, the latest on September 30, 2026, and lists 46 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
NHA
Device class
2
Regulation
872.3630
Medical specialty
Dental
Implant
Yes

Makers by country

CountryMakers
United States105
South Korea44
Germany34
Israel28
Switzerland20
China14
Spain10
Sweden7
France6
Taiwan5
Brazil4
Italy4
Japan4
Costa Rica3
Vietnam2
Canada2
Belgium2
Turkey2
India2
Denmark1
Australia1
Liechtenstein1
South Africa1
Andorra1
Thailand1
Czechia1
Portugal1
Hungary1
Lithuania1
United Kingdom1

Makers of Abutment, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Institut Straumann AGBASEL Basel-Stadt, SwitzerlandComplaint file establishment, Specification developer75January 22, 2026000api.fda.gov
Straumann Villeret SAVILLERET Bern, SwitzerlandManufacturer65January 22, 2026000api.fda.gov
ZimVie US Corp LLCPalm Beach Gardens, FL, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer35December 21, 20210160api.fda.gov
Nobel Biocare ABGOTEBORG Vastra Gotaland, SwedenSpecification developer34August 6, 2026000api.fda.gov
Nobel Biocare Services AGKloten Zurich, SwitzerlandSpecification developer34August 6, 2026000api.fda.gov
Straumann Manufacturing, Inc.Andover, MA, United StatesManufacturer27January 22, 2026000api.fda.gov
DENTSPLY IH Inc.Waltham, MA, United StatesContract manufacturer, Manufacturer24December 9, 2025000api.fda.gov
Straumann Manufacturing, Inc.Mansfield, TX, United StatesContract manufacturer, Manufacturer23May 7, 2026000api.fda.gov
etkon GMBHMarkkleeberg Saxony, GermanyManufacturer23February 21, 2025000api.fda.gov
Osstem Implant Co., Ltd.Gangseo-gu Seoul, South KoreaSpecification developer21January 29, 2026000api.fda.gov
PREAT CorporationSanta Maria, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer21April 16, 2026070api.fda.gov
Terrats Medical, S.L.Barbera del Valles Barcelona, SpainContract manufacturer, Manufacturer21June 9, 2026000api.fda.gov
JJGC Industria e Comercio de Materiais Dentarios SACuritiba Parana, BrazilManufacturer20July 1, 2026000api.fda.gov
Prismatik Dentalcraft, Inc.Irvine, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer18November 18, 2025010api.fda.gov
Osstem Implant Co., Ltd.Haeundae-gu Busan, South KoreaComplaint file establishment, Contract manufacturer, Manufacturer16March 4, 2026000api.fda.gov
Digital Age Dental Laboratories, Ltd.Vinh Tan Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer15January 22, 2024000api.fda.gov
Dentsply IH ABMOLNDAL Vastra Gotaland, SwedenExporter to the US, Manufacturer, Specification developer14December 9, 2025000api.fda.gov
Elos Medtech Pinol A/SGoerloese Hovedstaden, DenmarkContract manufacturer, Manufacturer14September 30, 2026000api.fda.gov
Thommen Medical, AGGRENCHEN Solothurn, SwitzerlandManufacturer14June 2, 2016000api.fda.gov
Biohorizons Implant Systems Inc.Birmingham, AL, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer13June 26, 2026000api.fda.gov
Dentis Co., Ltd.Daegu, South KoreaManufacturer13July 25, 2024000api.fda.gov
TruAbutment Korea Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer13October 9, 2024000api.fda.gov
Hiossen Inc.Fairless Hills, PA, United StatesManufacturer, Repackager or relabeler12May 14, 2026010api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.Cartago, Costa RicaManufacturer12July 12, 2024000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesManufacturer, Repackager or relabeler, Specification developer12April 9, 2026000api.fda.gov
Dentium Co., Ltd.Suwon-si Gyeonggi, South KoreaManufacturer11January 23, 2020000api.fda.gov
Medentika GMBHHuegelsheim Baden-Wurttemberg, GermanySpecification developer11May 7, 2026000api.fda.gov
Medentika GmbHCalw Baden-Wurttemberg, GermanyManufacturer11May 7, 2026000api.fda.gov
Sirona Dental Systems GmbHBensheim Hesse, GermanySpecification developer11November 15, 2021000api.fda.gov
Zest Anchors, LLCEscondido, CA, United StatesManufacturer11April 9, 2026000api.fda.gov
Truabutment Inc.Irvine, CA, United StatesManufacturer10October 9, 2024000api.fda.gov
Creodent Hudson ValleyFishkill, NY, United StatesManufacturer9February 10, 2026000api.fda.gov
MegaGen Implant Co., Ltd. (Research Laboratories)Daegu, South KoreaSpecification developer9January 13, 2025000api.fda.gov
Megagen Implant Co., Ltd.Daegu, South KoreaManufacturer9January 13, 2025000api.fda.gov
Altatec GMBHWIMSHEIM Baden-Wurttemberg, GermanyManufacturer8September 14, 2016000api.fda.gov
CAMLOG Biotechnologies GmbHBasel Basel-Stadt, SwitzerlandExporter to the US, Specification developer8September 14, 2016000api.fda.gov
Implant Solutions Pty Ltd (trading AS Osteon Medical)Mulgrave Victoria, AustraliaExporter to the US, Manufacturer8April 24, 2024000api.fda.gov
Talladium Espana, SLLLEIDA Lerida, SpainContract manufacturer, Manufacturer8January 29, 2026000api.fda.gov
Implant Direct Sybron Manufacturing LLCThousand Oaks, CA, United StatesManufacturer7June 20, 2023060api.fda.gov
ARUM DENTISTRY Co., Ltd.Yuseong-gu Daejeon, South KoreaManufacturer6November 25, 2024000api.fda.gov
Imagine Milling Technologies, LLCChantilly, VA, United StatesContract manufacturer, Manufacturer, Remanufacturer, Specification developer6June 27, 2026000api.fda.gov
Implant Protesis Dental 2004, S.L.Premia de Dalt Barcelona, SpainManufacturer6January 22, 2026000api.fda.gov
Ivoclar Vivadent AGSchaan, LiechtensteinManufacturer, Specification developer6November 16, 2020000api.fda.gov
Keystone Dental Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export6August 10, 2022000api.fda.gov
MIS Implants Technologies Ltd.BAR LEV INDUSTRIAL PARK Northern, IsraelContract manufacturer, Manufacturer6April 1, 2022000api.fda.gov
Sterngold Dental LLCAttleboro, MA, United StatesManufacturer6June 11, 2015000api.fda.gov
ARCH Medical Solutions - Escondido LLCEscondido, CA, United StatesManufacturer5November 8, 2012000api.fda.gov
B.T.I. Biotechnology Institute, S.L.Miñano Alava, SpainExporter to the US, Manufacturer, Specification developer5December 8, 2023000api.fda.gov
DIO CorporationHaeundae-gu Busan, South KoreaManufacturer5August 18, 2023000api.fda.gov
Innobiosurg Co., Ltd.Daejeon, South KoreaManufacturer5August 25, 2021000api.fda.gov
Neoss ABGoteborg Vastra Gotaland, SwedenExporter to the US, Manufacturer5May 17, 2022000api.fda.gov
Sirona Dental Systems GMBHBENSHEIM Hesse, GermanyManufacturer, Specification developer5April 30, 2025000api.fda.gov
Smart Denture Conversions, LLCApex, NC, United StatesManufacturer, Repackager or relabeler5January 17, 2025000api.fda.gov
Southern Implants (pty) LtdIRENE Gauteng, South AfricaExporter to the US, Manufacturer5August 1, 2023010api.fda.gov
The Argen CorporationSan Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler5April 24, 2024000api.fda.gov
The Argen CorporationSan Diego, CA, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler5April 24, 2024000api.fda.gov
Biodenta Swiss AGBerneck Sankt Gallen, SwitzerlandSpecification developer4December 1, 2015000api.fda.gov
Cendres+metaux SABiel/Bienne Bern, SwitzerlandContract manufacturer, Manufacturer4March 3, 2014000api.fda.gov
Cowellmedi Co., Ltd.Busan, South KoreaManufacturer4September 16, 2025000api.fda.gov
Open ImplantsSanta Ana, CA, United StatesManufacturer4June 26, 2025000api.fda.gov
Ossvis Co., Ltd.Anyang-si Gyeonggi, South KoreaManufacturer4December 5, 2024000api.fda.gov
Soadco, S.L.Escaldes-Engordany, AndorraManufacturer4April 24, 2023000api.fda.gov
A.B. Dental Devices LtdAshdod Southern, IsraelManufacturer, Specification developer3September 23, 2022000api.fda.gov
Implant Solutions Pty Ltd (trading AS Osteon Medical)Irvine, CA, United StatesManufacturer3March 9, 2024000api.fda.gov
Panthera Dental IncQuebec City, CanadaComplaint file establishment, Manufacturer3April 8, 2020000api.fda.gov
Rhein 83 SRLBOLOGNA Emilia-Romagna, ItalyComplaint file establishment, Manufacturer3April 9, 2018000api.fda.gov
Rodo Medical, IncTroy, MI, United StatesManufacturer3February 27, 2020000api.fda.gov
Sic Invent AGBasel Town Basel-Landschaft, SwitzerlandExporter to the US, Manufacturer3June 3, 2026000api.fda.gov
Simda Co.,ltd.Busan, South KoreaManufacturer3December 18, 2025000api.fda.gov
Sweden & Martina S.P.A.Due Carrare Padova, ItalyContract manufacturer, Manufacturer3February 1, 2018000api.fda.gov
Army Dental LaboratoryFort Eisenhower, GA, United StatesContract manufacturer, Manufacturer2December 1, 2022000api.fda.gov
Blue Sky Bio, LLCLibertyville, IL, United StatesSpecification developer2December 18, 2020000api.fda.gov
CBD Dental Lab, IncShenzhen Guangdong, ChinaManufacturer2October 17, 2023000api.fda.gov
Degudent GMBHHANAU Hesse, GermanyContract manufacturer, Manufacturer2May 7, 2024000api.fda.gov
Dental Direkt GmbHSpenge North Rhine-Westphalia, GermanyManufacturer2April 25, 2023000api.fda.gov
GC Corp.ITABASHI-KU Tokyo, JapanManufacturer2January 30, 2013000api.fda.gov
Geomedi Co., Ltd.Uiwang-si, Gyeonggi, South KoreaContract manufacturer, Exporter to the US, Manufacturer2June 16, 2025000api.fda.gov
Hager & Meisinger GMBHNEUSS North Rhine-Westphalia, GermanyManufacturer2November 21, 2016000api.fda.gov
Hiossen, Inc.Morrisville, PA, United StatesManufacturer2May 29, 2024000api.fda.gov
Hiossen, Inc.Buena Park, CA, United StatesManufacturer2May 29, 2024000api.fda.gov
Izenimplant Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer2January 12, 2024000api.fda.gov
Izenimplant Co., Ltd.Pyeongtaek-si Gyeonggi, South KoreaManufacturer2January 12, 2024000api.fda.gov
Implant Logistics / AMS MicromedicalSparta, WI, United StatesComplaint file establishment, Contract manufacturer, Manufacturer2August 15, 2023000api.fda.gov
Neobiotech Co., Ltd.Wonju-si Gangwon, South KoreaManufacturer2April 30, 2024000api.fda.gov
Nobel Biocare c/o Medicim NVMechelen Antwerpen, BelgiumComplaint file establishment, Manufacturer2November 29, 2017000api.fda.gov
Ot Medical GMBHBremen, GermanyManufacturer2April 13, 2016000api.fda.gov
Paltop Advanced Dental Solutions LtdCaesarea Central, IsraelContract manufacturer, Exporter to the US, Manufacturer2August 10, 2022000api.fda.gov
S.I.N. Implant System LtdaSao Paulo, BrazilManufacturer2October 17, 2025000api.fda.gov
SMD Dental LaboratoryHeungdeok-gu Cheongju-si Chungbuk, South KoreaManufacturer2February 21, 2025000api.fda.gov
Shinhung MST Co., Ltd.Wonju Si Gangwon, South KoreaManufacturer2February 3, 2023000api.fda.gov
WARANTEC Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer2October 2, 2023000api.fda.gov
Zentek Medical LLCManalapan, NJ, United StatesSpecification developer2October 15, 2025000api.fda.gov
ACH Medical Co., Ltd.Hwaseong-si Gyeonggi, South KoreaManufacturer1August 6, 2021000api.fda.gov
Adin Dental Implant Systems Ltd.Afula Northern, IsraelComplaint file establishment, Manufacturer1October 17, 2025000api.fda.gov
Allonus Tech Co., Ltd.Yangsan-si Gyeongnam, South KoreaManufacturer1December 17, 2024000api.fda.gov
American Dental Implant CorporationNew Castle, PA, United StatesSpecification developer1May 6, 2008000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceManufacturer1January 4, 2024000api.fda.gov
Avinent Implant System S.L.U.Santpedor Barcelona, SpainContract manufacturer, Manufacturer1October 24, 2013000api.fda.gov
BHI ImplantsAfula Northern, IsraelManufacturer, Repackager or relabeler1February 24, 2011000api.fda.gov
Blue Elephant IncWhittier, CA, United StatesSpecification developer1March 26, 2024000api.fda.gov
Buckeye Medical Technologies LLCWarren, OH, United StatesManufacturer1September 28, 2017000api.fda.gov
Chengdu Besmile Medical Technology Co., Ltd.Chengdu Sichuan, ChinaManufacturer1September 2, 2025000api.fda.gov
Cortex Dental Implants Industries Ltd.Shlomi Northern, IsraelManufacturer1January 29, 2019000api.fda.gov
CeramTec Schweiz GmbHSpreitenbach Aargau, SwitzerlandManufacturer1November 16, 2018000api.fda.gov
Daekwang I.D.MSeoul, South KoreaManufacturer1August 8, 2012000api.fda.gov
DENTSPLY Implants N.V.Hasselt Limburg, BelgiumManufacturer1March 3, 2020000api.fda.gov
Dentium USACypress, CA, United StatesManufacturer1December 16, 2016000api.fda.gov
Eclectic Inc.Hwaseong-si Gyeonggi, South KoreaManufacturer1October 18, 2024000api.fda.gov
Elegant Direct CorpBrooklyn, NY, United StatesManufacturer1July 22, 2020000api.fda.gov
EuroteknikaSALLANCHES Haute-Savoie, FranceComplaint file establishment, Manufacturer1March 4, 2025000api.fda.gov
GC Dental Products Corp.KASUGAI-SHI Aichi, JapanManufacturer1June 30, 2011000api.fda.gov
Infinetamed AGSarnen Obwalden, SwitzerlandComplaint file establishment, Manufacturer, Specification developer1July 28, 2025000api.fda.gov
IPB IncOgden, UT, United StatesManufacturer1June 6, 2022000api.fda.gov
Kat Implants, LLCPortsmouth, NH, United StatesManufacturer1February 2, 2009000api.fda.gov
Kelsey Dental LLCThe Woodlands, TX, United StatesSpecification developer1August 27, 2003000api.fda.gov
KJ Meditech Co., Ltd.Gwangju, South KoreaContract manufacturer, Manufacturer1August 8, 2012000api.fda.gov
Kuraray Noritake Dental Inc. Miyoshi PlantMIYOSHI Aichi, JapanManufacturer1May 24, 2024000api.fda.gov
Nobel Biocare AB, ProduktionKARLSKOGA Orebro, SwedenContract manufacturer, Manufacturer1August 6, 2026000api.fda.gov
Nobel Biocare Procera, LLCMahwah, NJ, United StatesComplaint file establishment, Contract manufacturer1July 24, 2014010api.fda.gov
Nobel Biocare Usa, LLCYorba Linda, CA, United StatesContract manufacturer, Manufacturer1August 6, 2026030api.fda.gov
Noris Medical Ltd.Nesher Haifa, IsraelManufacturer1February 4, 2022000api.fda.gov
Orangecad Med GMBHKarlsruhe Baden-Wurttemberg, GermanyManufacturer1December 23, 2025000api.fda.gov
Oneday Biotech Co., Ltd.Daegu, South KoreaManufacturer1February 21, 2024000api.fda.gov
Proto3000 Inc.Vaughan Ontario, CanadaManufacturer1January 11, 2023000api.fda.gov
Surgident Co., Ltd.Dong-gu Daegu, South KoreaManufacturer1May 17, 2019000api.fda.gov
Titan Implants, Inc.Bergenfield, NJ, United StatesManufacturer1March 23, 2005000api.fda.gov
Topway Dental Laboratory Co., LtdShenzhen Guangdong, ChinaManufacturer1October 20, 2004000api.fda.gov
Vita Zahnfabrik H. Rauter GMBH & Co. KG.BAD SACKINGEN Baden-Wurttemberg, GermanyManufacturer1June 30, 2016000api.fda.gov
Zeros Co., Ltd.Gimhae-si Gyeongnam, South KoreaManufacturer1July 28, 2025000api.fda.gov
Zfx GmbHDachau Bavaria, GermanyComplaint file establishment, Specification developer1March 1, 2024000api.fda.gov
etkon GMBHGRAEFELFING Bavaria, GermanyManufacturer1December 18, 2009000api.fda.gov
8dent Inc.Gimhae-si Gyeongnam, South KoreaManufacturer0000api.fda.gov
Abracadabra Implants Ltd.Or Yehuda Central, IsraelManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Accumedix, Inc.Libertyville, IL, United StatesContract manufacturer0000api.fda.gov
Aeton MedicalPennsauken, NJ, United StatesSpecification developer0000api.fda.gov
Alfa Gate - Mazen Ltd.kfar qara Northern, IsraelManufacturer0000api.fda.gov
Alien Milling TechnologiesGlendora, CA, United StatesContract manufacturer0000api.fda.gov
Alliance Global Technology Co., Ltd.Kaohsiung, TaiwanManufacturer0000api.fda.gov
Alpha Dent Implants GMBHPforzheim Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Arch Medical& Aerospace- Minneapolis, LLCNew Hope, MN, United StatesContract manufacturer0000api.fda.gov
ARDS Industries LtdPetah Tikva Central, IsraelManufacturer0000api.fda.gov
Argon Medical Productions & Vertriebs Gesellschaft MBH & Co.Bingen am Rhein Rhineland-Palatinate, GermanyManufacturer0000api.fda.gov
Aceso Dental Laboratory Company LimitedAn Phuoc Ward Dong Nai, VietnamContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract manufacturer0000api.fda.gov
Barksdale Dental Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
Bayou State Crown & Bridge LabBaton Rouge, LA, United StatesContract manufacturer0000api.fda.gov
BBF Sterilisationsservice GMBHKernen Baden-Wurttemberg, GermanyContract manufacturer, Contract sterilizer0000api.fda.gov
Bego Implant Systems GMBH & Co. KGBremen, GermanyManufacturer0000api.fda.gov
Bicon, LLCBoston, MA, United StatesSpecification developer0000api.fda.gov
Bio Concept Co., Ltd.Changzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Bioline Dental Implant Systems LtdMigdal Tefen Northern, IsraelSpecification developer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer0000api.fda.gov
Biostar Laboratorios SluPinto Madrid(Autonomous Community), SpainContract manufacturer0000api.fda.gov
Biotech Dental SASSalon de Provence Bouches-du-Rhone, FranceComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Biotem Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Biotech DentalEnglewood, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Burbank Dental LaboratoryBurbank, CA, United StatesContract manufacturer0000api.fda.gov
Ceramaret SABOLE Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Ceramtec GMBHLauf an der Pegnitz Bavaria, GermanyContract manufacturer0000api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.Luzhu District Taoyuan, TaiwanManufacturer0000api.fda.gov
Contech Medical, Inc.Providence, RI, United StatesContract manufacturer0000api.fda.gov
Cornerstone Biocomp Enterprises IncBristol, PA, United StatesContract manufacturer0000api.fda.gov
CPM Precision GMBHHirschberg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CSM ImplantDaegu, South KoreaManufacturer0000api.fda.gov
Cybermed Inc.Daejeon, South KoreaManufacturer0000api.fda.gov
D.A.N.D Metal Industries North Ltdmigdal tefen, P.O.B 51 Northern, IsraelContract manufacturer, Manufacturer0000api.fda.gov
D.S.P. Industrial Eireli EppCampo Largo Parana, BrazilManufacturer0000api.fda.gov
DDS Caribbean CorpGuaynabo, PR, United StatesContract manufacturer0000api.fda.gov
Denq Co., Ltd.Busan, South KoreaManufacturer0000api.fda.gov
Dental CraftersMarshfield, WI, United StatesContract manufacturer0000api.fda.gov
Dental Evolutions, IncBeverly Hills, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Dental Plus Usa, LLCSouth Jordan, UT, United StatesRepackager or relabeler, Reprocessor0000api.fda.gov
Dentin Implants Technologies Ltd.Mizpe Aviv Northern, IsraelManufacturer0000api.fda.gov
Diener AG Precision MachiningEmbrach Zurich, SwitzerlandContract manufacturer0000api.fda.gov
DIMPLO Ltd.Yeonje-gu Busan, South KoreaManufacturer0000api.fda.gov
Ditron Dental LtdAshkelon Southern, IsraelContract manufacturer, Manufacturer0000api.fda.gov
Dmi Technology LLCLynbrook, NY, United StatesSpecification developer0000api.fda.gov
Dot America, Inc.Columbia City, IN, United StatesContract manufacturer0000api.fda.gov
Dsi Dental Solutions LtdAshdod Southern, IsraelManufacturer0000api.fda.gov
Dti Implant SystemsKocaeli, TurkeyManufacturer0000api.fda.gov
DTS Digital Dental Labshenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Dentauspex CorporationDouliu Yunlin, TaiwanContract manufacturer0000api.fda.gov
Dentsply Implants Manufacturing GmbHHanau Hesse, GermanyContract manufacturer0000api.fda.gov
Edmonds Dental Prosthetics, Inc.Springfield, MO, United StatesContract manufacturer0000api.fda.gov
Elos Medtech Timmersdala ABTIMMERSDALA Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins Inpac Medizintechnik GMBHBirkenfeld Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Exceldent Dental Technology Development Co., Ltd.Zhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Express Dental LaboratoryMoore, OK, United StatesContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Evidence Implant Inc.Daegu, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Excel Medical Products, Inc.Wixom, MI, United StatesContract manufacturer0000api.fda.gov
F&B Technology Co., Ltd.Sasang-ku Busan, South KoreaManufacturer0000api.fda.gov
FMZ GMBHRostock Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer, Contract sterilizer0000api.fda.gov
Faulhaber Pinzetten KGFRITTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
GC Corporation-Fuji Oyama FactorySUNTO-GUN, Shizuoka-Ken, JapanManufacturer0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
GCDL, LLCProspect Heights, IL, United StatesContract manufacturer0000api.fda.gov
Gebr. Brasseler GMBH & Co. KGLEMGO North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Georgia High Tech Dental Lab IncLawrenceville, GA, United StatesContract manufacturer0000api.fda.gov
Gmi Dental Implantology, S.L.Lleida Lerida, SpainManufacturer0000api.fda.gov
GP Implants LtdNetanya Central, IsraelSpecification developer0000api.fda.gov
Gunter Medical GMBHPforzheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hexa Ceram Co., Ltd.Sansai Chiang Mai, ThailandContract manufacturer0000api.fda.gov
Hi Tec Implants, Ltd.HERZLIA Tel Aviv, IsraelManufacturer0000api.fda.gov
Highness Co.,ltd.Gyeongsangbuk-do Gyeongbuk, South KoreaManufacturer0000api.fda.gov
Hung Chun Bio-S Co., Ltd.Kaohsiung City, TaiwanManufacturer0000api.fda.gov
Himed, LLCOld Bethpage, NY, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Idis Co., Ltd.Bucheon-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Implacil De Bortoli Material Odontologico LtdaSao Paulo, BrazilManufacturer0000api.fda.gov
Infinitum Eta Ltd.Petach Tikva Central, IsraelContract manufacturer0000api.fda.gov
Inosys, Inc.New York, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Intai Technology Corp. Implants Business UnitTaichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Iq Implants LtdOmer Southern, IsraelManufacturer, Specification developer0000api.fda.gov
Ivoclar Vivadent Manufacturing GmbHNATURNO (BZ) Bolzano, ItalyContract manufacturer0000api.fda.gov
Ivoclar Vivadent Manufacturing, IncSomerset, NJ, United StatesContract manufacturer0000api.fda.gov
J Dental Care SRLModena, ItalyManufacturer0000api.fda.gov
Jamesb Dental StudioDumont, NJ, United StatesContract manufacturer0000api.fda.gov
Jiangsu Trausim Medical Instrument Co.,ltd.Changzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Josef Ganter Feinmechanik GMBHDAUCHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Khoury Dent Ltd Via Kasko K.N LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov
Klingel Medical Metal GMBHPforzheim Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Knight Dental GroupOldsmar, FL, United StatesContract manufacturer0000api.fda.gov
KTJ Medical Technology Co.,Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Lasak S.R.O.Praha 9 Praha, Hlavni Mesto, CzechiaContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Louisiana Dental Implant LabLafayette, LA, United StatesContract manufacturer0000api.fda.gov
LX Precision Portugal, Unipessoal, LdaCastelo de Paiva Aveiro, PortugalContract manufacturer0000api.fda.gov
LX Precision Shanghai Co LtdShanghai, ChinaContract manufacturer0000api.fda.gov
M/S Leixir Resources Pvt. LtdGURUGRAM Haryana, IndiaContract manufacturer0000api.fda.gov
Medical Systems And Devices International Ltd.Kiryat Ata Haifa, IsraelManufacturer0000api.fda.gov
Medimecca Co LtdSeoul, South KoreaManufacturer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
Mozo-Grau SAValladolid, SpainManufacturer0000api.fda.gov
Maestro Logistics, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
New Image Dental Laboratory, Inc.Morrow, GA, United StatesContract manufacturer0000api.fda.gov
New Perfect Dental LabSHENZHEN Guangdong, ChinaContract manufacturer0000api.fda.gov
Noga Medical Products Ltd.SHLOMI Northern, IsraelManufacturer0000api.fda.gov
Nova Implants LtdOr-Yehuda Tel Aviv, IsraelManufacturer, Specification developer0000api.fda.gov
Oco BiomedicalAlbuquerque, NM, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Oral Arts Dental Laboratories de Costa Rica LimitadaCurridabat San Jose, Costa RicaContract manufacturer0000api.fda.gov
Oral Arts Laboratory, Inc.Huntsville, AL, United StatesContract manufacturer0000api.fda.gov
Osseofuse International Inc.Las Vegas, NV, United StatesSpecification developer0000api.fda.gov
OsteoCentric Technologies,IncLogan, UT, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pan-Am Dental, Inc.Savannah, GA, United StatesContract manufacturer0000api.fda.gov
Paragon Implant Company, LLCLas Vegas, NV, United StatesManufacturer0000api.fda.gov
Paragon Implant MFG., LLCCalabasas, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Part Precision Sweden ABMariestad Vastra Gotaland, SwedenContract manufacturer0000api.fda.gov
Phen'x TechnologiesChassieu Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
POINTIMPLANT Co., LtdBusan, South KoreaComplaint file establishment, Manufacturer0000api.fda.gov
Precision One MedicalOceanside, CA, United StatesContract manufacturer0000api.fda.gov
Preferred Oral Design LimitadaAlajuela, San Rafael, Costa RicaContract manufacturer, Contract sterilizer0000api.fda.gov
Puracon GMBHRosenheim Bavaria, GermanyContract manufacturer0000api.fda.gov
Park Dental Research CorpArdmore, OK, United StatesManufacturer, Specification developer0000api.fda.gov
Precision One MedicalHoover, AL, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Quickdent Devices Private LimitedMumbai Maharashtra, IndiaSpecification developer0000api.fda.gov
Quality Tech Services, LLCShakopee, MN, United StatesContract manufacturer0000api.fda.gov
R2 Digital Milling TechnologiesWestwood, NJ, United StatesContract manufacturer0000api.fda.gov
RDJ Tov Implant LtdJerusalem, IsraelSpecification developer0000api.fda.gov
Rex Implants, IncColumbus, OH, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Rickli Micromecanique SAVauffelin Bern, SwitzerlandContract manufacturer0000api.fda.gov
RODO Digital ProstheticsTroy, MI, United StatesContract manufacturer0000api.fda.gov
Ritter Implants GmbH & Co. KGBiberach Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
S.G.S. International LtdBudapest, HungaryManufacturer0000api.fda.gov
Samaplast AGSankt Margrethen Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited SirketiIzmir, TurkeyManufacturer0000api.fda.gov
Schweizer Feinwerktechnik GMBHBad Boll Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SDS Swiss Dental SolutionsKreuzlingen Thurgau, SwitzerlandSpecification developer0000api.fda.gov
Selenium Medical S.A.S.La Rochelle Charente-Maritime, FranceContract manufacturer0000api.fda.gov
Sewon Medix, Inc.Busan, South KoreaManufacturer0000api.fda.gov
Shimmer Computerized Dental Technology Co.,ltdZhuhai Guangdong, ChinaContract manufacturer0000api.fda.gov
Snucone Co., Ltd.Dalseo-gu Daegu, South KoreaManufacturer0000api.fda.gov
Sudimplant SATOULOUSE Haute-Garonne, FranceManufacturer0000api.fda.gov
Suncoast Dental, Inc.Clearwater, FL, United StatesSpecification developer0000api.fda.gov
Superior Machined Products, Inc.Oceanside, CA, United StatesContract manufacturer0000api.fda.gov
Surcam Medical Devices And Developments LtdNahariya Northern, IsraelManufacturer0000api.fda.gov
Surgikor, LLCLos Angeles, CA, United StatesSpecification developer0000api.fda.gov
SynorossGlendale, CA, United StatesSpecification developer0000api.fda.gov
Shenzhen Jiahong Dental Technology Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
T. Strong Inc.Gimhae-si Gyeongnam, South KoreaManufacturer0000api.fda.gov
T.A.G. Medical Products Corporation LtdGAATON Northern, IsraelManufacturer0000api.fda.gov
TAV MedicalShlomi/Bar Lev Northern, IsraelContract manufacturer0000api.fda.gov
Trate LLCTamarac, FL, United StatesSpecification developer0000api.fda.gov
Trate UABKaunas Kauno Apskritis, LithuaniaContract manufacturer0000api.fda.gov
Tri Dental Implants Int. AGHuenenberg Zug, SwitzerlandManufacturer0000api.fda.gov
Theia Holding SALa Chaux-de-Fonds Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Unidental.co.krGwangmyeong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Uniqa Dental LtdNetanya Central, IsraelManufacturer0000api.fda.gov
United Dental Resources CorporationUniversity Park, IL, United StatesContract manufacturer0000api.fda.gov
Vulcan Custom DentalHoover, AL, United StatesContract manufacturer0000api.fda.gov
Wesley Coe (cambridge) LtdELY, CAMBS Cambridgeshire, United KingdomContract manufacturer0000api.fda.gov
Whitecap Dental Lab And Milling, LLCAmerican Fork, UT, United StatesContract manufacturer0000api.fda.gov
Willo ABVaxjo Kronoberg, SwedenContract manufacturer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesContract manufacturer0000api.fda.gov
Z-Systems AGOensingen Solothurn, SwitzerlandManufacturer0000api.fda.gov
Z7 LLCWhitehouse Station, NJ, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Zhuhai Crystal Dental Technology Co.,ltdZhuhai Guangdong, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Ziacom Implants SluPinto Madrid(Province), SpainComplaint file establishment, Manufacturer0000api.fda.gov
Zima International, Inc.Lehi, UT, United StatesContract manufacturer0000api.fda.gov
Zuga Medical, Inc.Cleveland, OH, United StatesManufacturer0000api.fda.gov
ZimVie Spain S.L.U.Paterna Valencia(Province), SpainContract manufacturer0000api.fda.gov

Updated September 30, 2026. 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.