K120736 is an FDA 510(k) clearance for the SR PHONARES II. This device is classified as a Denture, Plastic, Teeth (Class II - Special Controls, product code ELM).
Submitted by Ivoclar Vivadent, AG (Amherst, US). The FDA issued a Cleared decision on May 14, 2012, 66 days after receiving the submission on March 9, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3590.
| 510(k) Number | K120736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 2012 |
| Decision Date | May 14, 2012 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELM — Denture, Plastic, Teeth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3590 |