Data / Medical devices / Prosthesis, Condyle, Mandibular, Temporary
Prosthesis, Condyle, Mandibular, Temporary (NEI): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Prosthesis, Condyle, Mandibular, Temporary (product code NEI, Class 2, 21 CFR 872.4770). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on April 9, 2014, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NEI
- Device class
- 2
- Regulation
- 872.4770
- Medical specialty
- Dental
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Switzerland | 3 |
| Germany | 2 |
Makers of Prosthesis, Condyle, Mandibular, Temporary
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 |
|---|---|---|---|---|---|---|---|---|
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 3 | September 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| Synthes (USA) Products LLC | West Chester, PA, United States | Complaint file establishment, Specification developer | 3 | September 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| Synthes GMBH | Selzach Solothurn, Switzerland | Manufacturer | 2 | September 5, 2008 | 0 | 0 | 0 | api.fda.gov |
| Biomet Microfixation | Jacksonville, FL, United States | Manufacturer, Specification developer | 1 | August 6, 2001 | 0 | 0 | 0 | api.fda.gov |
| KLS-Martin L.P. | Jacksonville, FL, United States | Specification developer | 1 | July 27, 2001 | 0 | 0 | 0 | api.fda.gov |
| Osteomed | Addison, TX, United States | Manufacturer | 1 | July 8, 2004 | 0 | 0 | 0 | api.fda.gov |
| Stryker Leibinger GMBH & Co. KG | FREIBURG Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer | 1 | April 9, 2014 | 0 | 0 | 0 | api.fda.gov |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomet, Inc. | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Elmira) | Horseheads, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Switzerland Manufacturing GmbH (Mezzovico) | Mezzovico Ticino, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KLS Martin SE & Co. KG | Muhlheim/Donau Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 9, 2014. 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.