K163568 is an FDA 510(k) clearance for the SHOFU RESIN GLAZE. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on August 16, 2017, 240 days after receiving the submission on December 19, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K163568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2016 |
| Decision Date | August 16, 2017 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBD — Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |