# K083569: Surgybone

- Pathway: 510(k) (Abbreviated)
- Applicant: Silfradent S.R.L.
- Decided: Apr 1, 2009 after 119 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080220: Piezo Ultrasonic Device, Model Ultrasonic Bone Surgery; Ultrasonic Debridment Device, Italia Medica S.R.L. (2008) Summary page 1.
- K060274: Piezotome, Satelec (2006) Summary page 1.
- K043408: Piezosurgery Device, Piezosurgery S.R.L. (2005) Summary page 1.

## Indications for use
This device is a dental bone cutting instrument performing operations in the field of oral surgery.

Source page: https://510kreport.com/device/K083569
Methodology: https://510kreport.com/methodology