K240801
- 510(k) number
- K240801
- Device name
- BioSonic US200 Ultrasonic Scaler (60034537)
- Applicant
- Dent4you AG CH
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2024-07-01
- Date received
- 2024-03-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 3.7 MB · U.S. public domain
Also available from FDA: K240801.pdf
Official FDA record: K240801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.