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
| Country | Makers |
|---|---|
| United States | 105 |
| South Korea | 44 |
| Germany | 34 |
| Israel | 28 |
| Switzerland | 20 |
| China | 14 |
| Spain | 10 |
| Sweden | 7 |
| France | 6 |
| Taiwan | 5 |
| Brazil | 4 |
| Italy | 4 |
| Japan | 4 |
| Costa Rica | 3 |
| Vietnam | 2 |
| Canada | 2 |
| Belgium | 2 |
| Turkey | 2 |
| India | 2 |
| Denmark | 1 |
| Australia | 1 |
| Liechtenstein | 1 |
| South Africa | 1 |
| Andorra | 1 |
| Thailand | 1 |
| Czechia | 1 |
| Portugal | 1 |
| Hungary | 1 |
| Lithuania | 1 |
| United Kingdom | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Institut Straumann AG | BASEL Basel-Stadt, Switzerland | Complaint file establishment, Specification developer | 75 | January 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Straumann Villeret SA | VILLERET Bern, Switzerland | Manufacturer | 65 | January 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| ZimVie US Corp LLC | Palm Beach Gardens, FL, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer | 35 | December 21, 2021 | 0 | 16 | 0 | api.fda.gov |
| Nobel Biocare AB | GOTEBORG Vastra Gotaland, Sweden | Specification developer | 34 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare Services AG | Kloten Zurich, Switzerland | Specification developer | 34 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Straumann Manufacturing, Inc. | Andover, MA, United States | Manufacturer | 27 | January 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY IH Inc. | Waltham, MA, United States | Contract manufacturer, Manufacturer | 24 | December 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Straumann Manufacturing, Inc. | Mansfield, TX, United States | Contract manufacturer, Manufacturer | 23 | May 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| etkon GMBH | Markkleeberg Saxony, Germany | Manufacturer | 23 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, South Korea | Specification developer | 21 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| PREAT Corporation | Santa Maria, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 21 | April 16, 2026 | 0 | 7 | 0 | api.fda.gov |
| Terrats Medical, S.L. | Barbera del Valles Barcelona, Spain | Contract manufacturer, Manufacturer | 21 | June 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| JJGC Industria e Comercio de Materiais Dentarios SA | Curitiba Parana, Brazil | Manufacturer | 20 | July 1, 2026 | 0 | 0 | 0 | api.fda.gov |
| Prismatik Dentalcraft, Inc. | Irvine, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 18 | November 18, 2025 | 0 | 1 | 0 | api.fda.gov |
| Osstem Implant Co., Ltd. | Haeundae-gu Busan, South Korea | Complaint file establishment, Contract manufacturer, Manufacturer | 16 | March 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Digital Age Dental Laboratories, Ltd. | Vinh Tan Ward Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer | 15 | January 22, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dentsply IH AB | MOLNDAL Vastra Gotaland, Sweden | Exporter to the US, Manufacturer, Specification developer | 14 | December 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Elos Medtech Pinol A/S | Goerloese Hovedstaden, Denmark | Contract manufacturer, Manufacturer | 14 | September 30, 2026 | 0 | 0 | 0 | api.fda.gov |
| Thommen Medical, AG | GRENCHEN Solothurn, Switzerland | Manufacturer | 14 | June 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| Biohorizons Implant Systems Inc. | Birmingham, AL, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 13 | June 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dentis Co., Ltd. | Daegu, South Korea | Manufacturer | 13 | July 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| TruAbutment Korea Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 13 | October 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hiossen Inc. | Fairless Hills, PA, United States | Manufacturer, Repackager or relabeler | 12 | May 14, 2026 | 0 | 1 | 0 | api.fda.gov |
| Laboratorios Dentales De Zona Franca, S.A. | Cartago, Costa Rica | Manufacturer | 12 | July 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 12 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Dentium Co., Ltd. | Suwon-si Gyeonggi, South Korea | Manufacturer | 11 | January 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medentika GMBH | Huegelsheim Baden-Wurttemberg, Germany | Specification developer | 11 | May 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medentika GmbH | Calw Baden-Wurttemberg, Germany | Manufacturer | 11 | May 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GmbH | Bensheim Hesse, Germany | Specification developer | 11 | November 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Escondido, CA, United States | Manufacturer | 11 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Truabutment Inc. | Irvine, CA, United States | Manufacturer | 10 | October 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Creodent Hudson Valley | Fishkill, NY, United States | Manufacturer | 9 | February 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| MegaGen Implant Co., Ltd. (Research Laboratories) | Daegu, South Korea | Specification developer | 9 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Megagen Implant Co., Ltd. | Daegu, South Korea | Manufacturer | 9 | January 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Altatec GMBH | WIMSHEIM Baden-Wurttemberg, Germany | Manufacturer | 8 | September 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| CAMLOG Biotechnologies GmbH | Basel Basel-Stadt, Switzerland | Exporter to the US, Specification developer | 8 | September 14, 2016 | 0 | 0 | 0 | api.fda.gov |
| Implant Solutions Pty Ltd (trading AS Osteon Medical) | Mulgrave Victoria, Australia | Exporter to the US, Manufacturer | 8 | April 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Talladium Espana, SL | LLEIDA Lerida, Spain | Contract manufacturer, Manufacturer | 8 | January 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Implant Direct Sybron Manufacturing LLC | Thousand Oaks, CA, United States | Manufacturer | 7 | June 20, 2023 | 0 | 6 | 0 | api.fda.gov |
| ARUM DENTISTRY Co., Ltd. | Yuseong-gu Daejeon, South Korea | Manufacturer | 6 | November 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Imagine Milling Technologies, LLC | Chantilly, VA, United States | Contract manufacturer, Manufacturer, Remanufacturer, Specification developer | 6 | June 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Implant Protesis Dental 2004, S.L. | Premia de Dalt Barcelona, Spain | Manufacturer | 6 | January 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ivoclar Vivadent AG | Schaan, Liechtenstein | Manufacturer, Specification developer | 6 | November 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Keystone Dental Inc. | Irvine, CA, United States | Manufacturer, Manufacturer for export | 6 | August 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| MIS Implants Technologies Ltd. | BAR LEV INDUSTRIAL PARK Northern, Israel | Contract manufacturer, Manufacturer | 6 | April 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sterngold Dental LLC | Attleboro, MA, United States | Manufacturer | 6 | June 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| ARCH Medical Solutions - Escondido LLC | Escondido, CA, United States | Manufacturer | 5 | November 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| B.T.I. Biotechnology Institute, S.L. | Miñano Alava, Spain | Exporter to the US, Manufacturer, Specification developer | 5 | December 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| DIO Corporation | Haeundae-gu Busan, South Korea | Manufacturer | 5 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| Innobiosurg Co., Ltd. | Daejeon, South Korea | Manufacturer | 5 | August 25, 2021 | 0 | 0 | 0 | api.fda.gov |
| Neoss AB | Goteborg Vastra Gotaland, Sweden | Exporter to the US, Manufacturer | 5 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sirona Dental Systems GMBH | BENSHEIM Hesse, Germany | Manufacturer, Specification developer | 5 | April 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Smart Denture Conversions, LLC | Apex, NC, United States | Manufacturer, Repackager or relabeler | 5 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Southern Implants (pty) Ltd | IRENE Gauteng, South Africa | Exporter to the US, Manufacturer | 5 | August 1, 2023 | 0 | 1 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler | 5 | April 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| The Argen Corporation | San Diego, CA, United States | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 5 | April 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biodenta Swiss AG | Berneck Sankt Gallen, Switzerland | Specification developer | 4 | December 1, 2015 | 0 | 0 | 0 | api.fda.gov |
| Cendres+metaux SA | Biel/Bienne Bern, Switzerland | Contract manufacturer, Manufacturer | 4 | March 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cowellmedi Co., Ltd. | Busan, South Korea | Manufacturer | 4 | September 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Open Implants | Santa Ana, CA, United States | Manufacturer | 4 | June 26, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ossvis Co., Ltd. | Anyang-si Gyeonggi, South Korea | Manufacturer | 4 | December 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Soadco, S.L. | Escaldes-Engordany, Andorra | Manufacturer | 4 | April 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| A.B. Dental Devices Ltd | Ashdod Southern, Israel | Manufacturer, Specification developer | 3 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Implant Solutions Pty Ltd (trading AS Osteon Medical) | Irvine, CA, United States | Manufacturer | 3 | March 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Panthera Dental Inc | Quebec City, Canada | Complaint file establishment, Manufacturer | 3 | April 8, 2020 | 0 | 0 | 0 | api.fda.gov |
| Rhein 83 SRL | BOLOGNA Emilia-Romagna, Italy | Complaint file establishment, Manufacturer | 3 | April 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Rodo Medical, Inc | Troy, MI, United States | Manufacturer | 3 | February 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sic Invent AG | Basel Town Basel-Landschaft, Switzerland | Exporter to the US, Manufacturer | 3 | June 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Simda Co.,ltd. | Busan, South Korea | Manufacturer | 3 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sweden & Martina S.P.A. | Due Carrare Padova, Italy | Contract manufacturer, Manufacturer | 3 | February 1, 2018 | 0 | 0 | 0 | api.fda.gov |
| Army Dental Laboratory | Fort Eisenhower, GA, United States | Contract manufacturer, Manufacturer | 2 | December 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 2 | December 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| CBD Dental Lab, Inc | Shenzhen Guangdong, China | Manufacturer | 2 | October 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Degudent GMBH | HANAU Hesse, Germany | Contract manufacturer, Manufacturer | 2 | May 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Dental Direkt GmbH | Spenge North Rhine-Westphalia, Germany | Manufacturer | 2 | April 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| GC Corp. | ITABASHI-KU Tokyo, Japan | Manufacturer | 2 | January 30, 2013 | 0 | 0 | 0 | api.fda.gov |
| Geomedi Co., Ltd. | Uiwang-si, Gyeonggi, South Korea | Contract manufacturer, Exporter to the US, Manufacturer | 2 | June 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Hager & Meisinger GMBH | NEUSS North Rhine-Westphalia, Germany | Manufacturer | 2 | November 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hiossen, Inc. | Morrisville, PA, United States | Manufacturer | 2 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hiossen, Inc. | Buena Park, CA, United States | Manufacturer | 2 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 2 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Izenimplant Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 2 | January 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Implant Logistics / AMS Micromedical | Sparta, WI, United States | Complaint file establishment, Contract manufacturer, Manufacturer | 2 | August 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Neobiotech Co., Ltd. | Wonju-si Gangwon, South Korea | Manufacturer | 2 | April 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare c/o Medicim NV | Mechelen Antwerpen, Belgium | Complaint file establishment, Manufacturer | 2 | November 29, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ot Medical GMBH | Bremen, Germany | Manufacturer | 2 | April 13, 2016 | 0 | 0 | 0 | api.fda.gov |
| Paltop Advanced Dental Solutions Ltd | Caesarea Central, Israel | Contract manufacturer, Exporter to the US, Manufacturer | 2 | August 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| S.I.N. Implant System Ltda | Sao Paulo, Brazil | Manufacturer | 2 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| SMD Dental Laboratory | Heungdeok-gu Cheongju-si Chungbuk, South Korea | Manufacturer | 2 | February 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Shinhung MST Co., Ltd. | Wonju Si Gangwon, South Korea | Manufacturer | 2 | February 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| WARANTEC Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 2 | October 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zentek Medical LLC | Manalapan, NJ, United States | Specification developer | 2 | October 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| ACH Medical Co., Ltd. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | August 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Adin Dental Implant Systems Ltd. | Afula Northern, Israel | Complaint file establishment, Manufacturer | 1 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Allonus Tech Co., Ltd. | Yangsan-si Gyeongnam, South Korea | Manufacturer | 1 | December 17, 2024 | 0 | 0 | 0 | api.fda.gov |
| American Dental Implant Corporation | New Castle, PA, United States | Specification developer | 1 | May 6, 2008 | 0 | 0 | 0 | api.fda.gov |
| Anthogyr | SALLANCHES Haute-Savoie, France | Manufacturer | 1 | January 4, 2024 | 0 | 0 | 0 | api.fda.gov |
| Avinent Implant System S.L.U. | Santpedor Barcelona, Spain | Contract manufacturer, Manufacturer | 1 | October 24, 2013 | 0 | 0 | 0 | api.fda.gov |
| BHI Implants | Afula Northern, Israel | Manufacturer, Repackager or relabeler | 1 | February 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Blue Elephant Inc | Whittier, CA, United States | Specification developer | 1 | March 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Buckeye Medical Technologies LLC | Warren, OH, United States | Manufacturer | 1 | September 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu Sichuan, China | Manufacturer | 1 | September 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cortex Dental Implants Industries Ltd. | Shlomi Northern, Israel | Manufacturer | 1 | January 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| CeramTec Schweiz GmbH | Spreitenbach Aargau, Switzerland | Manufacturer | 1 | November 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Daekwang I.D.M | Seoul, South Korea | Manufacturer | 1 | August 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| DENTSPLY Implants N.V. | Hasselt Limburg, Belgium | Manufacturer | 1 | March 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dentium USA | Cypress, CA, United States | Manufacturer | 1 | December 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Eclectic Inc. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 1 | October 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Elegant Direct Corp | Brooklyn, NY, United States | Manufacturer | 1 | July 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Euroteknika | SALLANCHES Haute-Savoie, France | Complaint file establishment, Manufacturer | 1 | March 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| GC Dental Products Corp. | KASUGAI-SHI Aichi, Japan | Manufacturer | 1 | June 30, 2011 | 0 | 0 | 0 | api.fda.gov |
| Infinetamed AG | Sarnen Obwalden, Switzerland | Complaint file establishment, Manufacturer, Specification developer | 1 | July 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| IPB Inc | Ogden, UT, United States | Manufacturer | 1 | June 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kat Implants, LLC | Portsmouth, NH, United States | Manufacturer | 1 | February 2, 2009 | 0 | 0 | 0 | api.fda.gov |
| Kelsey Dental LLC | The Woodlands, TX, United States | Specification developer | 1 | August 27, 2003 | 0 | 0 | 0 | api.fda.gov |
| KJ Meditech Co., Ltd. | Gwangju, South Korea | Contract manufacturer, Manufacturer | 1 | August 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Kuraray Noritake Dental Inc. Miyoshi Plant | MIYOSHI Aichi, Japan | Manufacturer | 1 | May 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare AB, Produktion | KARLSKOGA Orebro, Sweden | Contract manufacturer, Manufacturer | 1 | August 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nobel Biocare Procera, LLC | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 1 | July 24, 2014 | 0 | 1 | 0 | api.fda.gov |
| Nobel Biocare Usa, LLC | Yorba Linda, CA, United States | Contract manufacturer, Manufacturer | 1 | August 6, 2026 | 0 | 3 | 0 | api.fda.gov |
| Noris Medical Ltd. | Nesher Haifa, Israel | Manufacturer | 1 | February 4, 2022 | 0 | 0 | 0 | api.fda.gov |
| Orangecad Med GMBH | Karlsruhe Baden-Wurttemberg, Germany | Manufacturer | 1 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Oneday Biotech Co., Ltd. | Daegu, South Korea | Manufacturer | 1 | February 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Proto3000 Inc. | Vaughan Ontario, Canada | Manufacturer | 1 | January 11, 2023 | 0 | 0 | 0 | api.fda.gov |
| Surgident Co., Ltd. | Dong-gu Daegu, South Korea | Manufacturer | 1 | May 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Titan Implants, Inc. | Bergenfield, NJ, United States | Manufacturer | 1 | March 23, 2005 | 0 | 0 | 0 | api.fda.gov |
| Topway Dental Laboratory Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | October 20, 2004 | 0 | 0 | 0 | api.fda.gov |
| Vita Zahnfabrik H. Rauter GMBH & Co. KG. | BAD SACKINGEN Baden-Wurttemberg, Germany | Manufacturer | 1 | June 30, 2016 | 0 | 0 | 0 | api.fda.gov |
| Zeros Co., Ltd. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 1 | July 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zfx GmbH | Dachau Bavaria, Germany | Complaint file establishment, Specification developer | 1 | March 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| etkon GMBH | GRAEFELFING Bavaria, Germany | Manufacturer | 1 | December 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| 8dent Inc. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abracadabra Implants Ltd. | Or Yehuda Central, Israel | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accumedix, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aeton Medical | Pennsauken, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alfa Gate - Mazen Ltd. | kfar qara Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alien Milling Technologies | Glendora, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alliance Global Technology Co., Ltd. | Kaohsiung, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alpha Dent Implants GMBH | Pforzheim Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arch Medical& Aerospace- Minneapolis, LLC | New Hope, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARDS Industries Ltd | Petah Tikva Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Productions & Vertriebs Gesellschaft MBH & Co. | Bingen am Rhein Rhineland-Palatinate, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aceso Dental Laboratory Company Limited | An Phuoc Ward Dong Nai, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baechler Feintech AG | Hoelstein Basel-Landschaft, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Barksdale Dental Laboratory, Inc. | Huntsville, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bayou State Crown & Bridge Lab | Baton Rouge, LA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BBF Sterilisationsservice GMBH | Kernen Baden-Wurttemberg, Germany | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bego Implant Systems GMBH & Co. KG | Bremen, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bicon, LLC | Boston, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bio Concept Co., Ltd. | Changzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioline Dental Implant Systems Ltd | Migdal Tefen Northern, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biostar Laboratorios Slu | Pinto Madrid(Autonomous Community), Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotech Dental SAS | Salon de Provence Bouches-du-Rhone, France | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotem Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotech Dental | Englewood, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Burbank Dental Laboratory | Burbank, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ceramaret SA | BOLE Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ceramtec GMBH | Lauf an der Pegnitz Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| COHO Advanced Materials Tech. Co., Ltd. | Luzhu District Taoyuan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Contech Medical, Inc. | Providence, RI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cornerstone Biocomp Enterprises Inc | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPM Precision GMBH | Hirschberg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CSM Implant | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cybermed Inc. | Daejeon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D.A.N.D Metal Industries North Ltd | migdal tefen, P.O.B 51 Northern, Israel | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| D.S.P. Industrial Eireli Epp | Campo Largo Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DDS Caribbean Corp | Guaynabo, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Denq Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Crafters | Marshfield, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Evolutions, Inc | Beverly Hills, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Plus Usa, LLC | South Jordan, UT, United States | Repackager or relabeler, Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentin Implants Technologies Ltd. | Mizpe Aviv Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Diener AG Precision Machining | Embrach Zurich, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DIMPLO Ltd. | Yeonje-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ditron Dental Ltd | Ashkelon Southern, Israel | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dmi Technology LLC | Lynbrook, NY, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dot America, Inc. | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dsi Dental Solutions Ltd | Ashdod Southern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dti Implant Systems | Kocaeli, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DTS Digital Dental Lab | shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentauspex Corporation | Douliu Yunlin, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Implants Manufacturing GmbH | Hanau Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edmonds Dental Prosthetics, Inc. | Springfield, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elos Medtech Timmersdala AB | TIMMERSDALA Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins Inpac Medizintechnik GMBH | Birkenfeld Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Express Dental Laboratory | Moore, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evidence Implant Inc. | Daegu, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excel Medical Products, Inc. | Wixom, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| F&B Technology Co., Ltd. | Sasang-ku Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FMZ GMBH | Rostock Mecklenburg-Western Pomerania, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frueh Verpackungstechnik AG | Fehraltorf Zurich, Switzerland | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faulhaber Pinzetten KG | FRITTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Corporation-Fuji Oyama Factory | SUNTO-GUN, Shizuoka-Ken, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GCDL, LLC | Prospect Heights, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gebr. Brasseler GMBH & Co. KG | LEMGO North Rhine-Westphalia, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Georgia High Tech Dental Lab Inc | Lawrenceville, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gmi Dental Implantology, S.L. | Lleida Lerida, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GP Implants Ltd | Netanya Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gunter Medical GMBH | Pforzheim Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexa Ceram Co., Ltd. | Sansai Chiang Mai, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi Tec Implants, Ltd. | HERZLIA Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Highness Co.,ltd. | Gyeongsangbuk-do Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hung Chun Bio-S Co., Ltd. | Kaohsiung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Himed, LLC | Old Bethpage, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipp Medical AG | Renquishausen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Idis Co., Ltd. | Bucheon-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Implacil De Bortoli Material Odontologico Ltda | Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infinitum Eta Ltd. | Petach Tikva Central, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inosys, Inc. | New York, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intai Technology Corp. Implants Business Unit | Taichung City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iq Implants Ltd | Omer Southern, Israel | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing GmbH | NATURNO (BZ) Bolzano, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivoclar Vivadent Manufacturing, Inc | Somerset, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J Dental Care SRL | Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jamesb Dental Studio | Dumont, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Trausim Medical Instrument Co.,ltd. | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Josef Ganter Feinmechanik GMBH | DAUCHINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Khoury Dent Ltd Via Kasko K.N Ltd | Karmiel Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klingel Medical Metal GMBH | Pforzheim Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Knight Dental Group | Oldsmar, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KTJ Medical Technology Co.,Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lasak S.R.O. | Praha 9 Praha, Hlavni Mesto, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Louisiana Dental Implant Lab | Lafayette, LA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LX Precision Portugal, Unipessoal, Lda | Castelo de Paiva Aveiro, Portugal | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LX Precision Shanghai Co Ltd | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Leixir Resources Pvt. Ltd | GURUGRAM Haryana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Systems And Devices International Ltd. | Kiryat Ata Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medimecca Co Ltd | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mozo-Grau SA | Valladolid, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maestro Logistics, LLC | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Image Dental Laboratory, Inc. | Morrow, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| New Perfect Dental Lab | SHENZHEN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noga Medical Products Ltd. | SHLOMI Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nova Implants Ltd | Or-Yehuda Tel Aviv, Israel | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oco Biomedical | Albuquerque, NM, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oral Arts Dental Laboratories de Costa Rica Limitada | Curridabat San Jose, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oral Arts Laboratory, Inc. | Huntsville, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osseofuse International Inc. | Las Vegas, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OsteoCentric Technologies,Inc | Logan, UT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pan-Am Dental, Inc. | Savannah, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Implant Company, LLC | Las Vegas, NV, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Implant MFG., LLC | Calabasas, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Part Precision Sweden AB | Mariestad Vastra Gotaland, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phen'x Technologies | Chassieu Auvergne-Rhone-Alpes, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| POINTIMPLANT Co., Ltd | Busan, South Korea | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Preferred Oral Design Limitada | Alajuela, San Rafael, Costa Rica | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Puracon GMBH | Rosenheim Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Park Dental Research Corp | Ardmore, OK, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision One Medical | Hoover, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quickdent Devices Private Limited | Mumbai Maharashtra, India | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Shakopee, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R2 Digital Milling Technologies | Westwood, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RDJ Tov Implant Ltd | Jerusalem, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rex Implants, Inc | Columbus, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rickli Micromecanique SA | Vauffelin Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RODO Digital Prosthetics | Troy, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ritter Implants GmbH & Co. KG | Biberach Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S.G.S. International Ltd | Budapest, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samaplast AG | Sankt Margrethen Sankt Gallen, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Limited Sirketi | Izmir, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Schweizer Feinwerktechnik GMBH | Bad Boll Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SDS Swiss Dental Solutions | Kreuzlingen Thurgau, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Selenium Medical S.A.S. | La Rochelle Charente-Maritime, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sewon Medix, Inc. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shimmer Computerized Dental Technology Co.,ltd | Zhuhai Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Snucone Co., Ltd. | Dalseo-gu Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sudimplant SA | TOULOUSE Haute-Garonne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suncoast Dental, Inc. | Clearwater, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Superior Machined Products, Inc. | Oceanside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surcam Medical Devices And Developments Ltd | Nahariya Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgikor, LLC | Los Angeles, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synoross | Glendale, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Jiahong Dental Technology Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T. Strong Inc. | Gimhae-si Gyeongnam, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| T.A.G. Medical Products Corporation Ltd | GAATON Northern, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TAV Medical | Shlomi/Bar Lev Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trate LLC | Tamarac, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trate UAB | Kaunas Kauno Apskritis, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri Dental Implants Int. AG | Huenenberg Zug, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Theia Holding SA | La Chaux-de-Fonds Neuchatel, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unidental.co.kr | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uniqa Dental Ltd | Netanya Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| United Dental Resources Corporation | University Park, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vulcan Custom Dental | Hoover, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wesley Coe (cambridge) Ltd | ELY, CAMBS Cambridgeshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Whitecap Dental Lab And Milling, LLC | American Fork, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Willo AB | Vaxjo Kronoberg, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Z-Systems AG | Oensingen Solothurn, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Z7 LLC | Whitehouse Station, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai Crystal Dental Technology Co.,ltd | Zhuhai Guangdong, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ziacom Implants Slu | Pinto Madrid(Province), Spain | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zima International, Inc. | Lehi, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zuga Medical, Inc. | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZimVie Spain S.L.U. | Paterna Valencia(Province), Spain | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.