K251811
- 510(k) number
- K251811
- Device name
- Motor and Apex Module (MaAM)
- Applicant
- Dentsply Sirona, Inc. PA · US
- Product code
- EBW — Controller, Foot, Handpiece And Cord
- Decision date
- 2025-08-25
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251811.pdf
Official FDA record: K251811
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.