Motor and Apex Module (MaAM)
FDA 510(k) K251811 · Dentsply Sirona, Inc.
510(k) numberK251811
Submission
- Device name
- Motor and Apex Module (MaAM)
- Applicant
- Dentsply Sirona, Inc.
York, PA, US - Received
- June 12, 2025
- Decision date
- August 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Motor and Apex Module (MaAM) cleared by the FDA?
Motor and Apex Module (MaAM) (K251811) received a 510(k) decision of Substantially Equivalent on August 25, 2025, 74 days after the submission was received.
What is the product code of K251811?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.