# K113717: Ultrasonic Scaler

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Mar 5, 2013 after 442 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 K031421 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031421: Ultrasonic Scaler, Models Varios 350 Lux, Varios 350 (NO Light), Varios 550, Varios 150 Lux, Varios 150 (NO Light), Nakanishi, Inc. (2004) Summary page 1.

## Indications for use
This product is intended only for dental clinic /dental office use. This device generates ultrasonic iuves intended for use in dental applications such as scaling, root canal treatment,periodontaland cavity preparation.

Source page: https://510kreport.com/device/K113717
Methodology: https://510kreport.com/methodology