K220873 is an FDA 510(k) clearance for the Perceptive electric dental motor and control unit. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Lares Research (Chico, US). The FDA issued a Cleared decision on December 15, 2022, 265 days after receiving the submission on March 25, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K220873 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2022 |
| Decision Date | December 15, 2022 |
| Days to Decision | 265 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 |