K152243 is an FDA 510(k) clearance for the One Coat 7 Universal. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Coltene/Whaledent AG (Altstatten, CH). The FDA issued a Cleared decision on December 9, 2015, 121 days after receiving the submission on August 10, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K152243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2015 |
| Decision Date | December 09, 2015 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLE - Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |