# K033764: SP Newtron Module

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Mar 1, 2004 after 90 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: 3 generations back to K942139 (1995). 3 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972026: SP4044 & SP4055 Lux Modules, Satelec (1997) Summary page 1.

## Most influential descendants
- K050895: Surpasson P5 Newtron (2005), 11 descendants of its own
- K202906: EndoPilot2 (2021), 4 descendants of its own
- K102218: Compact Piezo P2K, Powercare (2011), 3 descendants of its own
- K140965: Multipiezo Pro, Multipiezo (2014), 2 descendants of its own
- K071424: Pmax Newtron XS (2007), 2 descendants of its own

## Indications for use
Scaling * Interdental junction treatment * Tooth neck and subgingival treatment * Treatment of large deposits * Treatment of coating and tobacco stains * Interproximal treatment * Prosthesis conservative/restorative: o Inlay/onlay condensation o Amalgam plugging o Loosening prostheses (bridge, crown, post, pivot...) Endodontia: * Canal preparation * Canal cleaning * Canal filling * Gutta percha condensation * Treatment resumption * Retro surgery * Micro retro surgery * Surface smoothing after burring Periodontia: * Root planing * Initial therapy * Treatment of periodontal pockets * Treatment of furcations * Maintenance therapy * Implant maintenance

Source page: https://510kreport.com/device/K033764
Methodology: https://510kreport.com/methodology