The following data is part of a premarket notification filed by Bauer, Cheng & Associates, Inc. with the FDA for Coltene Brilliant.
| Device ID | K840085 |
| 510k Number | K840085 |
| Device Name: | COLTENE BRILLIANT |
| Classification | Material, Tooth Shade, Resin |
| Applicant | BAUER, CHENG & ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-10 |
| Decision Date | 1984-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00656310 | K840085 | 000 |
| J00673320 | K840085 | 000 |
| J00673330 | K840085 | 000 |
| J00673340 | K840085 | 000 |
| J00673350 | K840085 | 000 |
| J00673360 | K840085 | 000 |
| J00673370 | K840085 | 000 |
| J00673380 | K840085 | 000 |
| J00673670 | K840085 | 000 |
| J00673740 | K840085 | 000 |
| J00656300 | K840085 | 000 |
| J0065630L0 | K840085 | 000 |
| J00673300 | K840085 | 000 |