The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Temporary Crown & Bridge Resin.
| Device ID | K060881 |
| 510k Number | K060881 |
| Device Name: | TEMPORARY CROWN & BRIDGE RESIN |
| Classification | Crown And Bridge, Temporary, 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-31 |
| Decision Date | 2006-05-16 |
| Summary: | summary |