# K173905: Surgic Pro, Surgic Pro+

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Jun 19, 2018 after 179 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: 3 generations back to K002469 (2001). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161957: W&H Implantmed SI-1015 incl. Accessories, W&H Dentalwerk Burmoos GmbH (2016) Summary page 4.

## Most influential descendants
- K201192: Impla-NX (Model: ISE-270M) (2021), 1 descendant of its own
- K231562: ELEC ENGINE (Model: ISE-170L) (2025), 0 descendants of its own
- K233117: Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (2024), 0 descendants of its own
- K220831: Dental Implantation Systems, Dental Electrical Motors (2022), 0 descendants of its own
- K211584: Oral Surgery Contra (2021), 0 descendants of its own

## Indications for use
Surgic Pro+ / Surgic Pro The Surgic Pro+ / Surgic Pro 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. SG20/ X-SG20L This medical device is for oral surgery and dental implant operation. This device is driven by an electronic micromotor for oral surgery and dental implant. The device is intended to transmit the rotation of the power source at different gear ratios, thereby moving instruments such as surgical burs or surgical drills to cut the maxilla / mandible during oral surgery and dental implant.

Source page: https://510kreport.com/device/K173905
Methodology: https://510kreport.com/methodology