# K112188: Piezotome Solo

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon, Inc.
- Decided: Feb 3, 2012 after 189 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 K020833 (2002). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091252: Implant Center 2, Satelec (2009) Summary page 2.

## Most influential descendants
- K172137: Piezotome Cube (2018), 0 descendants of its own

## Indications for use
The intended use of the Satelec PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

Source page: https://510kreport.com/device/K112188
Methodology: https://510kreport.com/methodology