# K100401: Swerv Magnetostrictive Ultrasonic Scaler System

- Pathway: 510(k) (Traditional)
- Applicant: Hu-Friedy Mfg. Co., Inc.
- Decided: Mar 30, 2010 after 42 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: 2 generations back to K864996 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970123: Dentsply Cavitron SPS Scaler System, Dentsply Intl. (1997) Summary page 1.
- K033705: Bobcat Pro Scaler System, Model G-130, Dentsply International (2003) Summary page 1.

## Indications for use
This device generates ultrasonic vibrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.

Source page: https://510kreport.com/device/K100401
Methodology: https://510kreport.com/methodology