# K131997: Newtron Booster

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: Nov 26, 2013 after 151 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: 5 generations back to K942139 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050895: Surpasson P5 Newtron, Satelec (2005) Summary page 2.
- K113430: Proultra Piezo Ultrasonic, Satelec - Acteon Group (2012) Summary page 2.

## Indications for use
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).

Source page: https://510kreport.com/device/K131997
Methodology: https://510kreport.com/methodology