The following data is part of a premarket notification filed by Anthogyr Sas with the FDA for Axiom Reg.
| Device ID | K131066 |
| 510k Number | K131066 |
| Device Name: | AXIOM REG |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Contact | Therese Candau |
| Correspondent | Therese Candau ANTHOGYR SAS 2237, AVENUE ANDRE LASQUIN Sallanches, FR 74700 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-16 |
| Decision Date | 2014-02-21 |
| Summary: | summary |