The following data is part of a premarket notification filed by Confi-dental Products Co. with the FDA for Crystalline 'fluorite' Core Build-up Material.
| Device ID | K933199 |
| 510k Number | K933199 |
| Device Name: | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL |
| Classification | Cement, Dental |
| Applicant | CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Contact | Sharon A Lutton |
| Correspondent | Sharon A Lutton CONFI-DENTAL PRODUCTS CO. 385 S. PIERCE AVE. COLORADO TECH CENTER Louisville, CO 80027 -3017 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-15 |
| Decision Date | 1994-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816519020602 | K933199 | 000 |
| 00816519020572 | K933199 | 000 |
| 00816519020565 | K933199 | 000 |