# K091331: Piezotome 2

- Pathway: 510(k) (Traditional)
- Applicant: Satelec
- Decided: Dec 11, 2009 after 220 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.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060274: Piezotome, Satelec (2006) Summary page 1.

## Most influential descendants
- K163610: PIEZOTOME M+, PIEZOTOME M+ Handpiece (2017), 0 descendants of its own

## Indications for use
The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

Source page: https://510kreport.com/device/K091331
Methodology: https://510kreport.com/methodology