K023035 is an FDA 510(k) clearance for the SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on December 2, 2002, 81 days after receiving the submission on September 12, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K023035 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 12, 2002 |
| Decision Date | December 02, 2002 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELM — Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |