K192809 is an FDA 510(k) clearance for the Dental Handpiece. This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).
Submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on August 25, 2020, 329 days after receiving the submission on October 1, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K192809 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2019 |
| Decision Date | August 25, 2020 |
| Days to Decision | 329 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFA - Handpiece, Belt And/or Gear Driven, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |