K161604 is an FDA 510(k) clearance for the OSSTEM Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on October 17, 2016, 129 days after receiving the submission on June 10, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K161604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2016 |
| Decision Date | October 17, 2016 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |