Data / Medical devices / France / Sudimplant SA
Sudimplant SA: FDA-registered device maker in TOULOUSE Haute-Garonne, France, 2 510(k) clearances
Sudimplant SA is registered with the FDA (registration 3005643710) in TOULOUSE Haute-Garonne, France. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 9, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005643710
- Address
- 24 Impasse Rene Couzinet, TOULOUSE Haute-Garonne, France, 31500
- Owner or operator
- SUDIMPLANT SA (9084682)
- Roles
- Manufacturer
- First device listed
- March 22, 2006
- Registered through
- 2026
- Brand names listed
- TBR IDE@ CONIC, TBR Zirconnect
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 9, 2007 | K070935 | T.B.R. ZIRCONNECT | DZE | Substantially Equivalent | Sudimplant SA | accessdata.fda.gov |
| February 16, 2006 | K050956 | TBR IDEA CONIC/CONIC | DZE | Substantially Equivalent | Sudimplant SA | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2007. 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.