K131068 is an FDA 510(k) clearance for the TEETHMATE DESENSITIZER SET. This device is classified as a Liner, Cavity, Calcium Hydroxide (Class II - Special Controls, product code EJK).
Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on August 27, 2013, 132 days after receiving the submission on April 17, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3250.
| 510(k) Number | K131068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2013 |
| Decision Date | August 27, 2013 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJK — Liner, Cavity, Calcium Hydroxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3250 |