Data / Medical devices / Pin, Retentive And Splinting, And Accessory Instruments
Pin, Retentive And Splinting, And Accessory Instruments (EBL): 36 FDA-registered makers in 15 countries
36 establishments in 15 countries are registered with the FDA to make Pin, Retentive And Splinting, And Accessory Instruments (product code EBL, Class 1, 21 CFR 872.3740). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on November 9, 2000, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EBL
- Device class
- 1
- Regulation
- 872.3740
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Germany | 7 |
| China | 4 |
| Pakistan | 2 |
| South Korea | 2 |
| India | 2 |
| Switzerland | 2 |
| Israel | 1 |
| Brazil | 1 |
| Sweden | 1 |
| Liechtenstein | 1 |
| Australia | 1 |
| United Kingdom | 1 |
| Turkey | 1 |
| Italy | 1 |
Makers of Pin, Retentive And Splinting, And Accessory Instruments
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 |
|---|---|---|---|---|---|---|---|---|
| Abracadabra Implants Ltd. | Or Yehuda Central, Israel | 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 | |
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Ali Impex | SIALKOT, Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotem Co., Ltd. | Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bredent GMBH & Co.kg | SENDEN Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Nice Medical Instrument Limited Company | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CM Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentatus AB | SPANGA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentistry Elevated | Wellsville, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dufner Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edenta Etablissement | SCHAANWALD Mauren, Liechtenstein | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Erskine Dental | MACKSVILLE New South Wales, Australia | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FAIRFAX MEDICAL PRODUCTS Ltd | London London, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gesco Healthcare Private Limited | CHENNAI, Tamil Nadu, India | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager & Werken GMBH | DUISBURG,DE-NOTA Hamburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager Worldwide, Inc. | Hickory, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harald Nordin S.A. | Montreux Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospimed MFG | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | Konya, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lenjoy Medical Engineering, Inc. | Gardena, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Maison Dentaire / Medirel SA | Agno Ticino, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MC Bio S.R.L. | Lomazzo Como, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcare Solutions GMBH | Emmingen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rudolf Storz GMBH | EMMINGEN Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Rogin Medical Co., Ltd | shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 9, 2000. 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.