K994224 is an FDA 510(k) clearance for the PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on January 31, 2000, 47 days after receiving the submission on December 15, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K994224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 1999 |
| Decision Date | January 31, 2000 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |