# K151023: Compact Piezo Led

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: Aug 5, 2015 after 111 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: 7 generations back to K896749 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102218: Compact Piezo P2K, Powercare, Mectron S.P.A. (2011) Summary page 5.
- K140965: Multipiezo Pro, Multipiezo, Mectron S.P.A. (2014) Summary page 5.

## Indications for use
The Compact Piezo Led is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the following dental applications: • Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits; • Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation and cleaning; • Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde preparation; • Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.

Source page: https://510kreport.com/device/K151023
Methodology: https://510kreport.com/methodology