The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Flowable Hybrid.
| Device ID | K980298 |
| 510k Number | K980298 |
| Device Name: | FLOWABLE HYBRID |
| 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 | 1998-01-27 |
| Decision Date | 1998-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D779701MWO0 | K980298 | 000 |
| D7797011A10 | K980298 | 000 |
| D7797011A20 | K980298 | 000 |
| D7797011A30 | K980298 | 000 |
| D7797011A40 | K980298 | 000 |
| D7797011B10 | K980298 | 000 |
| D7797011B20 | K980298 | 000 |
| D7797011B30 | K980298 | 000 |
| D7797011C20 | K980298 | 000 |
| D7797011C30 | K980298 | 000 |
| D7797011C40 | K980298 | 000 |
| D7797011CO0 | K980298 | 000 |
| D7797011D30 | K980298 | 000 |
| D7797011MI0 | K980298 | 000 |
| D779701A350 | K980298 | 000 |
| D77970110W0 | K980298 | 000 |