The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Insure Match Mate Porcelain Veneer Try-in System.
| Device ID | K894477 |
| 510k Number | K894477 |
| Device Name: | INSURE MATCH MATE PORCELAIN VENEER TRY-IN 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 | 1989-07-18 |
| Decision Date | 1990-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7796041070 | K894477 | 000 |
| EDEL6041020 | K894477 | 000 |
| EDEL6041030 | K894477 | 000 |
| EDEL6041040 | K894477 | 000 |
| EDEL6041050 | K894477 | 000 |
| EDEL6041060 | K894477 | 000 |
| EDEL6041070 | K894477 | 000 |
| D7796041010 | K894477 | 000 |
| D7796041020 | K894477 | 000 |
| D7796041030 | K894477 | 000 |
| D7796041040 | K894477 | 000 |
| D7796041050 | K894477 | 000 |
| D7796041060 | K894477 | 000 |
| EDEL6041010 | K894477 | 000 |