K182881 is an FDA 510(k) clearance for the Bone Screw, Bone Tack. This device is classified as a Screw, Fixation, Intraosseous (Class II - Special Controls, product code DZL).
Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on August 9, 2019, 298 days after receiving the submission on October 15, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K182881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2018 |
| Decision Date | August 09, 2019 |
| Days to Decision | 298 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4880 |