# K062731: Ultrasonic Scaler, Varios 560

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: May 1, 2007 after 230 days
- Product code: ELC (Scaler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 872.4850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device, Varios 560, an electric ultrasonic scaler, is intended for use with an appropriate tip for following use. - Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for Minimal Intervention / Finishing / Trimming / Polishing /Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)

Source page: https://510kreport.com/device/K062731
Methodology: https://510kreport.com/methodology