# K091227: Piezosurgery 3; Osstem Piezo

- Pathway: 510(k) (Traditional)
- Applicant: Piezosurgery S.R.L.
- Decided: Dec 29, 2009 after 245 days
- Product code: DZI (Drill, Bone, Powered)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896749 (1990). 6 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K052518: Piezosurgery, Piezosurgery S.R.L. (2005) Summary page 2.

## Most influential descendants
- 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
- K111290: Piezo Bone Surgery (2011), 0 descendants of its own

## Indications for use
The Piezosurgery 3 is intended for use in the following dental applications: - Bone cutting for use in oral surgery - 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/K091227
Methodology: https://510kreport.com/methodology