The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Insure Porcelain Veneer Bonding System.
| Device ID | K873356 |
| 510k Number | K873356 |
| Device Name: | INSURE PORCELAIN VENEER BONDING SYSTEM |
| Classification | Cement, Dental |
| Applicant | COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Contact | Michael O'malley |
| Correspondent | Michael O'malley COSMEDENT, INC. 5419 NORTH SHERIDAN RD. Chicago, IL 60640 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-20 |
| Decision Date | 1987-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL6051020 | K873356 | 000 |
| EDEL6021060 | K873356 | 000 |
| EDEL6021070 | K873356 | 000 |
| EDEL6021080 | K873356 | 000 |
| EDEL6051010 | K873356 | 000 |
| D7796021010 | K873356 | 000 |
| D7796021020 | K873356 | 000 |
| D7796021030 | K873356 | 000 |
| D7796021040 | K873356 | 000 |
| D7796021050 | K873356 | 000 |
| EDEL6021050 | K873356 | 000 |
| EDEL6021040 | K873356 | 000 |
| EDEL6021030 | K873356 | 000 |
| EDEL6051030 | K873356 | 000 |
| EDEL6051040 | K873356 | 000 |
| EDEL6051050 | K873356 | 000 |
| EDEL6051060 | K873356 | 000 |
| EDEL6051070 | K873356 | 000 |
| EDEL6051080 | K873356 | 000 |
| EDEL605ACL0 | K873356 | 000 |
| EDEL6021010 | K873356 | 000 |
| EDEL6021020 | K873356 | 000 |
| D7796021060 | K873356 | 000 |
| D7796021070 | K873356 | 000 |
| D7796120CL0 | K873356 | 000 |
| D7796120W10 | K873356 | 000 |
| D7796120W20 | K873356 | 000 |
| D7796120W30 | K873356 | 000 |
| D7796120W40 | K873356 | 000 |
| D7797120CL0 | K873356 | 000 |
| D7797120W10 | K873356 | 000 |
| D7797120W20 | K873356 | 000 |
| D7797120W30 | K873356 | 000 |
| D779605ACL0 | K873356 | 000 |
| D7796051080 | K873356 | 000 |
| D7796051070 | K873356 | 000 |
| D7796021080 | K873356 | 000 |
| D7796021140 | K873356 | 000 |
| D7796021150 | K873356 | 000 |
| D7796051010 | K873356 | 000 |
| D7796051020 | K873356 | 000 |
| D7796051030 | K873356 | 000 |
| D7796051040 | K873356 | 000 |
| D7796051050 | K873356 | 000 |
| D7796051060 | K873356 | 000 |
| D7797120W40 | K873356 | 000 |