# K080220: Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Italia Medica S.R.L.
- Decided: Jul 28, 2008 after 181 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K083569: Surgybone (2009), 0 descendants of its own

## Indications for use
The UBS Ultrasonic Bone Surgery and the UDD Ultrasonic Debridment Device are bone cutting instruments intended for use in oral surgery.

Source page: https://510kreport.com/device/K080220
Methodology: https://510kreport.com/methodology