K230641
- 510(k) number
- K230641
- Device name
- Ultrasonic Scaler Tips
- Applicant
- Guilin Refine Medical Instrument Co., Ltd. CN
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2023-11-21
- Date received
- 2023-03-08
- 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: K230641.pdf
Official FDA record: K230641
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.