# K102218: Compact Piezo P2K, Powercare

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: Jan 24, 2011 after 171 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 K896749 (1990). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091227: Piezosurgery 3; Osstem Piezo, Piezosurgery S.R.L. (2009) Summary page 1.
- K033764: SP Newtron Module, Satelec (2004) Summary page 1.

## Most influential descendants
- K140965: Multipiezo Pro, Multipiezo (2014), 2 descendants of its own
- K223173: Proxeo ULTRA (PB-510, PB-520 and PB-530) (2023), 0 descendants of its own
- K151023: Compact Piezo Led (2015), 0 descendants of its own

## Indications for use
The Compact Piezo P2K and Powercare devices are ultrasonic scalers intended for use, with the appropriate associated insert tips, in the following dental applications: Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits. Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning. Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation. Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Source page: https://510kreport.com/device/K102218
Methodology: https://510kreport.com/methodology