# K140965: Multipiezo Pro, Multipiezo

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: Aug 20, 2014 after 127 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: 6 generations back to K896749 (1990). 12 ancestors in all.
2 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)
- K022328: Ems Piezon Master 600, Electro Medical Systems SA (2002) Summary page 6.
- K102218: Compact Piezo P2K, Powercare, Mectron S.P.A. (2011) Summary page 6.

## Most influential descendants
- 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 Multipiezo Pro and Multipiezo are piezoelectric ultrasonic dental scalers intended for use, with the appropriate associated tip inserts, in the following dental applications: Scaling: All general procedures for removal of supragingival/subgingival 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: All general restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation, implants/restorations cleaning.

Source page: https://510kreport.com/device/K140965
Methodology: https://510kreport.com/methodology