K202786 is an FDA 510(k) clearance for the Dental Low-speed Handpieces and Accessories. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).
Submitted by Microp Technology (Taiwan), Inc. (Chiayi City, TW). The FDA issued a Cleared decision on September 3, 2021, 346 days after receiving the submission on September 22, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K202786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2020 |
| Decision Date | September 03, 2021 |
| Days to Decision | 346 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 |