# K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 20, 2024 after 267 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- Device class: 1
- Regulation: 21 CFR 872.4200
- 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 K990682 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 5.
- K161957: W&H Implantmed SI-1015 incl. Accessories, W&H Dentalwerk Burmoos GmbH (2016) Summary page 5.
- K161213: XSmart iQ, Dentsply Sirona (2017) Summary page 5.

## Indications for use
The Surgic Pro2 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Source page: https://510kreport.com/device/K233117
Methodology: https://510kreport.com/methodology