The following data is part of a premarket notification filed by Anthogyr Sas with the FDA for Anthofit Oi, Anthofit He, Ossfit And Axiom.
| Device ID | K101913 |
| 510k Number | K101913 |
| Device Name: | ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Contact | Eric Geneve |
| Correspondent | Eric Geneve ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-08 |
| Decision Date | 2011-03-11 |
| Summary: | summary |