K223340
- 510(k) number
- K223340
- Device name
- EDS Calculus Softener TURBO CR
- Applicant
- Essential Dental Systems, Inc. NJ · US
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2023-12-11
- Date received
- 2022-11-01
- 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: K223340.pdf
Official FDA record: K223340
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.