K251811 is an FDA 510(k) clearance for the Motor and Apex Module (MaAM). This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on August 25, 2025, 74 days after receiving the submission on June 12, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K251811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2025 |
| Decision Date | August 25, 2025 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |