The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Cosmedent Core Paste.
| Device ID | K040994 |
| 510k Number | K040994 |
| Device Name: | COSMEDENT CORE PASTE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Contact | James L Sandrik |
| Correspondent | James L Sandrik COSMEDENT, INC. 401 NORTH MICHIGAN AVE. SUITE 2500 Chicago, IL 60611 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-16 |
| Decision Date | 2004-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7796227A20 | K040994 | 000 |
| EDEL62210W0 | K040994 | 000 |
| EDEL6221A20 | K040994 | 000 |
| EDEL62270B0 | K040994 | 000 |
| EDEL62270W0 | K040994 | 000 |
| EDEL6227A20 | K040994 | 000 |
| D77962210B0 | K040994 | 000 |
| D77962210W0 | K040994 | 000 |
| D7796221A20 | K040994 | 000 |
| D77962270B0 | K040994 | 000 |
| D77962270W0 | K040994 | 000 |
| EDEL62210B0 | K040994 | 000 |