The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Multiple (tooth Desensitizer).
| Device ID | K052263 |
| 510k Number | K052263 |
| Device Name: | MULTIPLE (TOOTH DESENSITIZER) |
| Classification | Varnish, Cavity |
| 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 | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-19 |
| Decision Date | 2005-12-16 |
| Summary: | summary |