Motor and Apex Module (MaAM)
K-Number: K251811 · 2025-08-25
ApplicantDentsply Sirona, Inc.
Decision Date2025-08-25
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Motor and Apex Module (MaAM) is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-08-25 under approval number K251811. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Motor and Apex Module (MaAM)?
Motor and Apex Module (MaAM) is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K251811.
When was Motor and Apex Module (MaAM) approved by the FDA?
Motor and Apex Module (MaAM) received FDA 510(k) clearance on 2025-08-25, under approval number K251811.
What company makes Motor and Apex Module (MaAM)?
Motor and Apex Module (MaAM) is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for Motor and Apex Module (MaAM)?
The FDA product code for Motor and Apex Module (MaAM) is EBW.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.