K260773
- 510(k) number
- K260773
- Device name
- Varios Combi Pro2
- Applicant
- Nakanishi, Inc. JP
- Product code
- ELC — Scaler, Ultrasonic
- Decision date
- 2026-03-10
- Date received
- 2026-03-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260773.pdf
Official FDA record: K260773
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.