K050013 is an FDA 510(k) clearance for the RETRACTOFOAM. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on February 9, 2005, 37 days after receiving the submission on January 3, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K050013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 2005 |
| Decision Date | February 09, 2005 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | ELW - Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |