The following data is part of a premarket notification filed by Odontit Systeme with the FDA for Odontit Osseointegrated Implants System.
| Device ID | K915375 |
| 510k Number | K915375 |
| Device Name: | ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ODONTIT SYSTEME 8309 BYRANT DR. Bethesda, MD 20817 |
| Contact | Neal Dunning |
| Correspondent | Neal Dunning ODONTIT SYSTEME 8309 BYRANT DR. Bethesda, MD 20817 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D985HE419060 | K915375 | 000 |
| D985HE359030 | K915375 | 000 |
| D985HE359020 | K915375 | 000 |
| D985HE359010 | K915375 | 000 |
| D985HE358030 | K915375 | 000 |
| D985HE358020 | K915375 | 000 |
| D985HE358010 | K915375 | 000 |
| D985HE356000 | K915375 | 000 |
| D985HE355500 | K915375 | 000 |
| D985HE355000 | K915375 | 000 |
| D985HE354050 | K915375 | 000 |
| D985HE354030 | K915375 | 000 |
| D985HE359040 | K915375 | 000 |
| D985HE359050 | K915375 | 000 |
| D985HE419050 | K915375 | 000 |
| D985HE419040 | K915375 | 000 |
| D985HE419030 | K915375 | 000 |
| D985HE419020 | K915375 | 000 |
| D985HE419010 | K915375 | 000 |
| D985HE416100 | K915375 | 000 |
| D985HE416000 | K915375 | 000 |
| D985HE415500 | K915375 | 000 |
| D985HE415020 | K915375 | 000 |
| D985HE415010 | K915375 | 000 |
| D985HE415000 | K915375 | 000 |
| D985HE352000 | K915375 | 000 |