K221814 is an FDA 510(k) clearance for the OK Handpiece. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Jaintek Co.,Ltd (Ansan-Si, KR). The FDA issued a Cleared decision on July 15, 2022, 23 days after receiving the submission on June 22, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K221814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2022 |
| Decision Date | July 15, 2022 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFB - Handpiece, Air-powered, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |