The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamel Esthetic Restorative System, Modification.
| Device ID | K921820 |
| 510k Number | K921820 |
| Device Name: | RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATION |
| 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 | 1992-04-14 |
| Decision Date | 1992-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL7011DM0 | K921820 | 000 |
| D7796061LI0 | K921820 | 000 |
| D7796061MI0 | K921820 | 000 |
| D77960620W1 | K921820 | 000 |
| D7796062351 | K921820 | 000 |
| D7796062A11 | K921820 | 000 |
| D7796062A21 | K921820 | 000 |
| D7796062A31 | K921820 | 000 |
| D7796062A41 | K921820 | 000 |
| D7796062B01 | K921820 | 000 |
| D7796062B11 | K921820 | 000 |
| D7796062B21 | K921820 | 000 |
| D7796062B31 | K921820 | 000 |
| D7796062B41 | K921820 | 000 |
| D7796062C11 | K921820 | 000 |
| D7796062C21 | K921820 | 000 |
| D7796061D40 | K921820 | 000 |
| D7796061D30 | K921820 | 000 |
| D7796061D20 | K921820 | 000 |
| D77960610W0 | K921820 | 000 |
| D7796061A10 | K921820 | 000 |
| D7796061A20 | K921820 | 000 |
| D7796061A30 | K921820 | 000 |
| D7796061A40 | K921820 | 000 |
| D7796061B00 | K921820 | 000 |
| D7796061B10 | K921820 | 000 |
| D7796061B20 | K921820 | 000 |
| D7796061B30 | K921820 | 000 |
| D7796061B40 | K921820 | 000 |
| D7796061C10 | K921820 | 000 |
| D7796061C20 | K921820 | 000 |
| D7796061C30 | K921820 | 000 |
| D7796061C40 | K921820 | 000 |
| D7796061CO0 | K921820 | 000 |
| D7796062C31 | K921820 | 000 |
| D7796062C41 | K921820 | 000 |
| D7796062CO1 | K921820 | 000 |
| D7796161B10 | K921820 | 000 |
| D7796161B20 | K921820 | 000 |
| D7796161B30 | K921820 | 000 |
| D7796161B40 | K921820 | 000 |
| D7796161BO0 | K921820 | 000 |
| D7796161C10 | K921820 | 000 |
| D7796161C20 | K921820 | 000 |
| D7796161C30 | K921820 | 000 |
| D7796161C40 | K921820 | 000 |
| D7796161CO0 | K921820 | 000 |
| D7796161D20 | K921820 | 000 |
| D7796161D30 | K921820 | 000 |
| D7796161D40 | K921820 | 000 |
| D7796161MI0 | K921820 | 000 |
| D779616A350 | K921820 | 000 |
| D7796161A40 | K921820 | 000 |
| D7796161A30 | K921820 | 000 |
| D7796161A20 | K921820 | 000 |
| D7796062D21 | K921820 | 000 |
| D7796062D31 | K921820 | 000 |
| D7796062D41 | K921820 | 000 |
| D7796062LI1 | K921820 | 000 |
| D7796062MI1 | K921820 | 000 |
| D7796062MW1 | K921820 | 000 |
| D779606A350 | K921820 | 000 |
| D779606MWO0 | K921820 | 000 |
| D77961310W0 | K921820 | 000 |
| D7796131LI0 | K921820 | 000 |
| D779613SB10 | K921820 | 000 |
| D779613SB20 | K921820 | 000 |
| D779613SB30 | K921820 | 000 |
| D77961610W0 | K921820 | 000 |
| D7796161A10 | K921820 | 000 |
| D779616MWO0 | K921820 | 000 |