The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Renamel Flowable Composite.
| Device ID | K974494 |
| 510k Number | K974494 |
| Device Name: | RENAMEL FLOWABLE COMPOSITE |
| Classification | Coating, Filling Material, Resin |
| 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 | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-28 |
| Decision Date | 1998-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDEL3011OP0 | K974494 | 000 |
| EDEL3011C30 | K974494 | 000 |
| EDEL3011C40 | K974494 | 000 |
| EDEL3011C50 | K974494 | 000 |
| EDEL3011D20 | K974494 | 000 |
| EDEL3011D30 | K974494 | 000 |
| EDEL3011D40 | K974494 | 000 |
| EDEL3011DI0 | K974494 | 000 |
| EDEL3011LI0 | K974494 | 000 |
| EDEL3011LO0 | K974494 | 000 |
| EDEL3011MI0 | K974494 | 000 |
| EDEL301A150 | K974494 | 000 |
| EDEL3011C20 | K974494 | 000 |
| EDEL3011C10 | K974494 | 000 |
| EDEL30110W0 | K974494 | 000 |
| EDEL3011A10 | K974494 | 000 |
| EDEL3011A20 | K974494 | 000 |
| EDEL3011A30 | K974494 | 000 |
| EDEL3011A40 | K974494 | 000 |
| EDEL3011A50 | K974494 | 000 |
| EDEL3011A60 | K974494 | 000 |
| EDEL3011B10 | K974494 | 000 |
| EDEL3011B20 | K974494 | 000 |
| EDEL3011B30 | K974494 | 000 |
| EDEL3011B40 | K974494 | 000 |
| EDEL301A250 | K974494 | 000 |
| EDEL301A350 | K974494 | 000 |
| D77930110W0 | K974494 | 000 |
| D7793011C40 | K974494 | 000 |
| D7793011C50 | K974494 | 000 |
| D7793011D20 | K974494 | 000 |
| D7793011D30 | K974494 | 000 |
| D7793011D40 | K974494 | 000 |
| D7793011DI0 | K974494 | 000 |
| D7793011LI0 | K974494 | 000 |
| D7793011LO0 | K974494 | 000 |
| D7793011MI0 | K974494 | 000 |
| D779301A150 | K974494 | 000 |
| D779301A250 | K974494 | 000 |
| D7793011C30 | K974494 | 000 |
| D7793011C20 | K974494 | 000 |
| D7793011A10 | K974494 | 000 |
| D7793011A20 | K974494 | 000 |
| D7793011A30 | K974494 | 000 |
| D7793011A40 | K974494 | 000 |
| D7793011A50 | K974494 | 000 |
| D7793011A60 | K974494 | 000 |
| D7793011B10 | K974494 | 000 |
| D7793011B20 | K974494 | 000 |
| D7793011B30 | K974494 | 000 |
| D7793011B40 | K974494 | 000 |
| D7793011C10 | K974494 | 000 |
| D779301A350 | K974494 | 000 |