K233844
- 510(k) number
- K233844
- Device name
- OdneClean
- Applicant
- Odne AG CH
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2024-08-08
- Date received
- 2023-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
510(k) Summary (official FDA PDF): K233844.pdf
Official FDA record: K233844
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.