# K071424: Pmax Newtron XS

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: Aug 24, 2007 after 93 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). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
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 1.

## Most influential descendants
- K132322: Newtron P5 XS B.Led (2014), 0 descendants of its own
- K132267: Newtron P5, Newtron P5 B.Led (2014), 0 descendants of its own

## Indications for use
The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications: Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a detailed description. Periodontics: Root planing Initial therapy Treatment of periodontal pockets Treatment of furcations Maintenance therapy Implant maintenance Endodontics: Canal preparation Canal cleaning Canal filling Gutta percha condensation Treatment resumption Retro Surgery Micro Retro Surgery Scaling (prophylaxis): Interdental junction treatment Tooth neck and subgingival treatment Treatment of large deposits Treatment of coating and tobacco stains Interproximal treatment Prosthesis (conservative/restorative): Inlay/onlay condensation Amalgam plugging Loosening prostheses (bridge, crown, post, pivot...)

Source page: https://510kreport.com/device/K071424
Methodology: https://510kreport.com/methodology