K112168 is an FDA 510(k) clearance for the COMPONEER. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Coltene/Whaledent AG (Cuyahoga Falls, US). The FDA issued a Cleared decision on November 21, 2011, 116 days after receiving the submission on July 28, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K112168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2011 |
| Decision Date | November 21, 2011 |
| Days to Decision | 116 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 |