Cleared Traditional

Motor and Apex Module (MaAM)

K251811 · Dentsply Sirona, Inc. · Dental
Aug 2025
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K251811 is an FDA 510(k) clearance for the Motor and Apex Module (MaAM), 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 review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K251811 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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