# K043408: Piezosurgery Device

- Pathway: 510(k) (Traditional)
- Applicant: Piezosurgery S.R.L.
- Decided: Jun 8, 2005 after 180 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 K042434 (2004). 1 ancestor in all.
21 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042434: Micro-Motorsystems MD20, SEM2, Highsurg 20 & DT55, Nouvag AG (2004) Summary page 1.

## Most influential descendants
- K060274: Piezotome (2006), 10 descendants of its own
- K083284: Piezosurgery Medical (2009), 9 descendants of its own
- K100410: Piezoelectric System (2010), 8 descendants of its own
- K132848: Piezosurgery Flex (2013), 6 descendants of its own
- K072146: Ems Piezon Master Surgery (2007), 6 descendants of its own

## Indications for use
The Piezosurgery device is a bone cutting instrument intended for use in oral surgery.

Source page: https://510kreport.com/device/K043408
Methodology: https://510kreport.com/methodology