# K172137: Piezotome Cube

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: May 3, 2018 after 290 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 K020833 (2002). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112188: Piezotome Solo, Satelec - Acteon, Inc. (2012) Summary page 5.

## Indications for use
The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

Source page: https://510kreport.com/device/K172137
Methodology: https://510kreport.com/methodology