The following data is part of a premarket notification filed by Cosmedent, Inc. with the FDA for Low Viscosity Composite Temporary (provisional) Material.
| Device ID | K980800 |
| 510k Number | K980800 |
| Device Name: | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL |
| Classification | Material, Tooth Shade, 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 | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D779505LS30 | K980800 | 000 |
| D779505LD20 | K980800 | 000 |
| D779505LB00 | K980800 | 000 |
| D779505LA20 | K980800 | 000 |
| D779505LA10 | K980800 | 000 |