# K132322: Newtron P5 XS B.Led

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: Mar 11, 2014 after 229 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: 6 generations back to K942139 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K071424: Pmax Newtron XS, Satelec - Acteon Group (2007) Summary page 2.

## Indications for use
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.

Source page: https://510kreport.com/device/K132322
Methodology: https://510kreport.com/methodology