K033773 is an FDA 510(k) clearance for the CONCEPT HP ADD-ON. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on January 15, 2004, 43 days after receiving the submission on December 3, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K033773 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2003 |
| Decision Date | January 15, 2004 |
| Days to Decision | 43 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 |