The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Cosmedent Pit & Fissure Sealant.
| Device ID | K042823 |
| 510k Number | K042823 |
| Device Name: | COSMEDENT PIT & FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D77961710W0 | K042823 | 000 |
| D7796170CL0 | K042823 | 000 |
| EDEL61710W0 | K042823 | 000 |
| EDEL6170CL0 | K042823 | 000 |