The following data is part of a premarket notification filed by I.t.c. Ent. with the FDA for Primodent Acrylic Teeth.
| Device ID | K926070 |
| 510k Number | K926070 |
| Device Name: | PRIMODENT ACRYLIC TEETH |
| Classification | Denture, Plastic, Teeth |
| Applicant | I.T.C. ENT. 2215 CHIMNEY SPRINGS DR. Marietta, GA 30062 |
| Contact | Peter Petric |
| Correspondent | Peter Petric I.T.C. ENT. 2215 CHIMNEY SPRINGS DR. Marietta, GA 30062 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-01 |
| Decision Date | 1994-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EPOLPRI01B10 | K926070 | 000 |
| EPOLPRI01B40 | K926070 | 000 |
| EPOLPRI01B30 | K926070 | 000 |
| EPOLPRI01B20 | K926070 | 000 |