K152830 is an FDA 510(k) clearance for the K3. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Osstem Implant Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 20, 2017, 569 days after receiving the submission on September 29, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K152830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2015 |
| Decision Date | April 20, 2017 |
| Days to Decision | 569 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |