K253254
- 510(k) number
- K253254
- Device name
- GBT Machine Airflow Prophylaxis Master
- Applicant
- E.M.S Electro Medical Systems S.A CH
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2026-01-28
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253254.pdf
Official FDA record: K253254
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.