K180657 is an FDA 510(k) clearance for the Resin for Temporary Crown & Bridge. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 7, 2018, 269 days after receiving the submission on March 13, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K180657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2018 |
| Decision Date | December 07, 2018 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |