The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Multiple Resin Tooth Bonding Agent.
| Device ID | K052501 |
| 510k Number | K052501 |
| Device Name: | MULTIPLE RESIN TOOTH BONDING AGENT |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-09-13 |
| Decision Date | 2005-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7796021160 | K052501 | 000 |
| EDEL6021160 | K052501 | 000 |