FDA 510(k) clearance · back to tracker

Motor and Apex Module (MaAM)

Dentsply Sirona, Inc. cleared K251811 on 2025-08-25, decision: substantially equivalent

K-number

K251811

Sponsor

Dentsply Sirona, Inc.

Device

Motor and Apex Module (MaAM)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-08-25

Product code

EBW

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.4200

Official FDA record

Open K251811on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.