# K211584: Oral Surgery Contra

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Aug 19, 2021 after 87 days
- Product code: KMW (Handpiece, Rotary Bone Cutting)
- 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: 4 generations back to K002469 (2001). 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)
- K173905: Surgic Pro, Surgic Pro+, Nakanishi, Inc. (2018) Summary page 4.

## Indications for use
Oral Surgery Contra is for oral surgery. This device is driven by an electronic micromotor for oral surgery and dental implant. This device aims to transfer the rotation of the power source with various gear ratios, and moves instruments such as a surgical bur to cut the maxillary/mandibular bone during oral surgery treatment.

Source page: https://510kreport.com/device/K211584
Methodology: https://510kreport.com/methodology