# K113530: Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jan 31, 2013 after 428 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
Longest line of descent: 1 generation back to K071447 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071447: Varios 75, Nakanishi, Inc. (2008) Summary page 1.

## Most influential descendants
- K251689: Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler System (VA170S11) (2025), 0 descendants of its own

## Indications for use
This device, Varios 970 / Varios 970 Lux, an electronic ultrasonicscaler is intendedfor use with an appropriate ip forfollowing use: - Scaling, Perto, Implant Maintenance, Endodontic, RetrogradeEndo, Restorative (for Minimal InterventioniFinishing/7'rimming/Polishing/CariesofDentin), Prosthetics (Condensation/Loosening /Plugging)

Source page: https://510kreport.com/device/K113530
Methodology: https://510kreport.com/methodology