K220346 is an FDA 510(k) clearance for the Lotus Prophy Angle. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Ajk Engineering, Inc. (Sommerville, US). The FDA issued a Cleared decision on November 7, 2022, 273 days after receiving the submission on February 7, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K220346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2022 |
| Decision Date | November 07, 2022 |
| Days to Decision | 273 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EGS - Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |