K181854 is an FDA 510(k) clearance for the OssBuilder System. 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 May 7, 2019, 300 days after receiving the submission on July 11, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4880.
| 510(k) Number | K181854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 11, 2018 |
| Decision Date | May 07, 2019 |
| Days to Decision | 300 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 |