The following data is part of a premarket notification filed by Odontit Sa with the FDA for Odont Hex System.
| Device ID | K961631 |
| 510k Number | K961631 |
| Device Name: | ODONT HEX SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ODONTIT SA AV. RIVADAVIA 5032 1-7 Buenos Aires, AR 1424 |
| Contact | Mario Gersberg |
| Correspondent | Mario Gersberg ODONTIT SA AV. RIVADAVIA 5032 1-7 Buenos Aires, AR 1424 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-29 |
| Decision Date | 1997-05-12 |