The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamelize Polishing Paste.
| Device ID | K862912 |
| 510k Number | K862912 |
| Device Name: | RENAMELIZE POLISHING PASTE |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Contact | Michael O'malley |
| Correspondent | Michael O'malley COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-01 |
| Decision Date | 1986-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7799061010 | K862912 | 000 |
| D7799060000 | K862912 | 000 |
| EDEL9061010 | K862912 | 000 |
| EDEL9060000 | K862912 | 000 |