The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Crystallessence.
| Device ID | K954988 |
| 510k Number | K954988 |
| Device Name: | CRYSTALLESSENCE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Contact | Sharon A Lutton |
| Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 416 SOUTH TAYLOR AVE. Louisville, CO 80027 -3028 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-31 |
| Decision Date | 1996-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020671 | K954988 | 000 |
| 00816519020190 | K954988 | 000 |
| 00816519020206 | K954988 | 000 |
| 00816519020213 | K954988 | 000 |
| 00816519020220 | K954988 | 000 |
| 00816519020237 | K954988 | 000 |
| 00816519020244 | K954988 | 000 |
| 00816519020251 | K954988 | 000 |
| 00816519020268 | K954988 | 000 |
| 00816519020275 | K954988 | 000 |
| 00816519020282 | K954988 | 000 |
| 00816519020183 | K954988 | 000 |