# K113152: Ultrasonic Surgery Machine

- Pathway: 510(k) (Traditional)
- Applicant: Dmetec.Co., Ltd.
- Decided: Jun 14, 2012 after 233 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 K042434 (2004). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072146: Ems Piezon Master Surgery, E.M.S Electro Medical Systems S.A (2007) Summary page 1.

## Most influential descendants
- K192033: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip (2020), 0 descendants of its own
- K131674: Prebent Plating with Virtual Surgical Planning (2013), 0 descendants of its own

## Indications for use
A device intended for use surgical procedure Including osteotomy, osteoplasty, Periodontal surgery and implantation

Source page: https://510kreport.com/device/K113152
Methodology: https://510kreport.com/methodology