# K220831: Dental Implantation Systems, Dental Electrical Motors

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Coxo Medical Instrument Co., Ltd.
- Decided: Sep 27, 2022 after 189 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 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 6.

## Indications for use
C-Sailor Pro: This device 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. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel. C-PUMA MASTER: The Dental Electrical Motor 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. This device is designed for use by a trained professional in the filed of general dentistry.

Source page: https://510kreport.com/device/K220831
Methodology: https://510kreport.com/methodology