The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Cyrstalline L3 Multi-use Hybrid Composite.
| Device ID | K946307 |
| 510k Number | K946307 |
| Device Name: | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE |
| 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 | 1994-12-28 |
| Decision Date | 1995-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020701 | K946307 | 000 |
| 00816519020114 | K946307 | 000 |
| 00816519020121 | K946307 | 000 |
| 00816519020138 | K946307 | 000 |
| 00816519020145 | K946307 | 000 |
| 00816519020152 | K946307 | 000 |
| 00816519020169 | K946307 | 000 |
| 00816519020176 | K946307 | 000 |
| 00816519020312 | K946307 | 000 |
| 00816519020107 | K946307 | 000 |
| 00816519020091 | K946307 | 000 |
| 00816519020015 | K946307 | 000 |
| 00816519020022 | K946307 | 000 |
| 00816519020039 | K946307 | 000 |
| 00816519020046 | K946307 | 000 |
| 00816519020053 | K946307 | 000 |
| 00816519020060 | K946307 | 000 |
| 00816519020077 | K946307 | 000 |
| 00816519020084 | K946307 | 000 |
| 00816519020329 | K946307 | 000 |
| 00816519020336 | K946307 | 000 |
| 00816519020442 | K946307 | 000 |
| 00816519020459 | K946307 | 000 |
| 00816519020466 | K946307 | 000 |
| 00816519020473 | K946307 | 000 |
| 00816519020480 | K946307 | 000 |
| 00816519020497 | K946307 | 000 |
| 00816519020503 | K946307 | 000 |
| 00816519020510 | K946307 | 000 |
| 00816519020435 | K946307 | 000 |
| 00816519020428 | K946307 | 000 |
| 00816519020343 | K946307 | 000 |
| 00816519020350 | K946307 | 000 |
| 00816519020367 | K946307 | 000 |
| 00816519020374 | K946307 | 000 |
| 00816519020381 | K946307 | 000 |
| 00816519020398 | K946307 | 000 |
| 00816519020404 | K946307 | 000 |
| 00816519020411 | K946307 | 000 |
| 00816519020008 | K946307 | 000 |