# K052518: Piezosurgery

- Pathway: 510(k) (Traditional)
- Applicant: Piezosurgery S.R.L.
- Decided: Nov 16, 2005 after 63 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 K896749 (1990). 5 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 12 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 2.

## Most influential descendants
- K091227: Piezosurgery 3; Osstem Piezo (2009), 5 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
- 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 Piezosurgery® device is intended for use in the following dental applications: - Removing supra and subgingival calculus deposits and stains from teeth - Periodontal pocket lavage with simultaneous ultrasonic tip movement - Scaling and root planing - Retrograde preparation of root canals

Source page: https://510kreport.com/device/K052518
Methodology: https://510kreport.com/methodology