# K254163: VarioSurg 4

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Dec 23, 2025 after 1 day
- 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 K073678 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073678: Variosurg, Nakanishi, Inc. (2008) Summary page 5.

## Indications for use
The VarioSurg 4 is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

Source page: https://510kreport.com/device/K254163
Methodology: https://510kreport.com/methodology