K-numberK251811
Device nameMotor and Apex Module (MaAM)
ApplicantDentsply Sirona, Inc.
Product codeEBW
Device classClass I
Decision dateAug 25, 2025
DecisionSubstantially Equivalent
Regulation872.4200
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The Motor and Apex Module (MaAM) is a control unit for dental procedures that operates up to three dental motors, an apex locator, and a peristaltic pump. The Midwest Power Lux motor drives straight and contra-angle handpieces for endodontic and general dentistry, while the Midwest Power Lux Implant motor is used for implant placement with sterile solution delivery. The apex locator helps dentists determine working length during root canal treatment.

Technological characteristics

The control module contains an internal component of a dental delivery system that receives electrical power from the delivery system and controls motor operation through delivery system instructions. The module supports manual apex locator use and combined use with motors. The same lip clip, file clamp, cable, and adapter components are shared between the proposed device and predicates for apex measurement, with two operational methods available: via file clamp alone or with a compatible contra-angle handpiece.

Test standards cited

ISO 14457 for dental motors; IEC 62471:2006 for photobiological safety of lamps and lamp systems; ISO 3964:2018 AMD1:2018 for dental coupling dimensions.

Substantial equivalence argument

The proposed device and predicate devices share identical technological characteristics, both providing a controller to operate electric micromotors for dental procedures by qualified practitioners. The control module is contained within the dental delivery system with the same power acquisition and user interface methods. The apex location technology uses the same established determination method evaluating electrical impedance, with identical shared components (lip clip, file clamp, cable). All testing demonstrated the proposed device meets specifications equivalent to the identified predicate devices.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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