# K110881: Ultrasonic Surgical Unit

- Pathway: 510(k) (Traditional)
- Applicant: Dong IL Technology, Ltd.
- Decided: Dec 16, 2011 after 261 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: 2 generations back to K042434 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043408: Piezosurgery Device, Piezosurgery S.R.L. (2005) Summary page 1.

## Most influential descendants
- K150076: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L (2015), 0 descendants of its own

## Indications for use
Ultrasonic Surgical Unit is a piezoelctric device for bone surgery that enables osteotomny and osteoplasty techniques to be applied to in dental use.

Source page: https://510kreport.com/device/K110881
Methodology: https://510kreport.com/methodology