# K972026: SP4044 & SP4055 Lux Modules

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Jul 9, 1997 after 37 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: 2 generations back to K942139 (1995). 2 ancestors in all.
21 later devices descend from it; 1 cites 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)
- K961158: Suprasson P5 Booster, Satelec (1996) Summary page 1.

## Most influential descendants
- K033764: SP Newtron Module (2004), 20 descendants of its own
- 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

## Indications for use
Scaling Endodontics Periodontics Please refer to the attached listing for a complete description. Scaling: Interdental junction treatment Tooth neck and subgingival treatment Treatment of large deposits Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Retro Surgery Plugging Amalgam plugging Loosening Prosthesis Loosening (crown, pivot locsening) Inlay/Onlay Condensation: Finish of inlay/onlay restorations Endodontia: Canal preparation Canal cleaning Canal filling Treatment resumption Prosthesis: Preparing in luted denture Surface smoothing after burring Micro Retro Surgery Gutta Condensation: Treatment resumption on gutta percha Post loosening Silver cone loosening Gutta percha condensation Periodontia: $Xeot planing Initial therapy Treatment of periodontal pockets Treatiment of furcations Maintenancs therapy

Source page: https://510kreport.com/device/K972026
Methodology: https://510kreport.com/methodology