# K150076: Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L

- Pathway: 510(k) (Traditional)
- Applicant: Dong IL Technology, Ltd.
- Decided: Jun 2, 2015 after 139 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: 3 generations back to K042434 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110881: Ultrasonic Surgical Unit, Dong IL Technology, Ltd. (2011) Summary page 4.

## Indications for use
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L are piezoelectric devices for surgery that enable mechanical ultrasound treatment, osteotomy and osteoplasty techniques to be applied in dental use.

Source page: https://510kreport.com/device/K150076
Methodology: https://510kreport.com/methodology