# K151248: Piezosurgery White

- Pathway: 510(k) (Traditional)
- Applicant: Mectron S.P.A.
- Decided: Sep 4, 2015 after 116 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: 1 generation back to K122322 (2012). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122322: Piezosurgery Touch, Mectron S.P.A. (2012) Summary page 4.

## Most influential descendants
- K171326: Piezosurgery White (2018), 0 descendants of its own
- K171958: Piezosurgery Touch, Piezosurgery White (2018), 0 descendants of its own

## Indications for use
The Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

Source page: https://510kreport.com/device/K151248
Methodology: https://510kreport.com/methodology