# K050895: Surpasson P5 Newtron

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Apr 20, 2005 after 12 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: 4 generations back to K942139 (1995). 4 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961158: Suprasson P5 Booster, Satelec (1996) Summary page 1.
- K033764: SP Newtron Module, Satelec (2004) Summary page 1.

## Most influential descendants
- K202906: EndoPilot2 (2021), 4 descendants of its own
- K071424: Pmax Newtron XS (2007), 2 descendants of its own
- K233865: X-Smart Pro; X-Smart Pro+ (2024), 1 descendant of its own
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own
- K242317: Integrated Endo System (Meet Endo-II) (2025), 0 descendants of its own

## Indications for use
Periodontics Endodontics Scaling Prosthesis 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/K050895
Methodology: https://510kreport.com/methodology