K151262 is an FDA 510(k) clearance for the Hyflex Heavy, Hyflex Mono, Hyflex Light. This device is classified as a Material, Impression (Class II - Special Controls, product code ELW).
Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on September 21, 2015, 131 days after receiving the submission on May 13, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3660.
| 510(k) Number | K151262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2015 |
| Decision Date | September 21, 2015 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | ELW — Material, Impression |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3660 |