# K111290: Piezo Bone Surgery

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Nov 18, 2011 after 196 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: 5 generations back to K896749 (1990). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.

## Indications for use
The Piezo Bone Surgery is intended for use in the following dental applications: - Bone culling 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 planning - Retrograde preparation of root canals

Source page: https://510kreport.com/device/K111290
Methodology: https://510kreport.com/methodology