The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamel Sculpt.
| Device ID | K993658 |
| 510k Number | K993658 |
| Device Name: | RENAMEL SCULPT |
| Classification | Material, Tooth Shade, Resin |
| 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-29 |
| Decision Date | 2000-01-18 |