K132115 is an FDA 510(k) clearance for the ABSOLUTE DENTIN 2. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on June 25, 2014, 351 days after receiving the submission on July 9, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K132115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2013 |
| Decision Date | June 25, 2014 |
| Days to Decision | 351 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |