# K230106: General Cutting Straight

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: May 24, 2023 after 131 days
- Product code: EGS (Handpiece, Contra- And Right-Angle Attachment, Dental)
- 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: 2 generations back to K071891 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132356: Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST, Scican GmbH (2014) Summary page 4.

## Indications for use
General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. General Cutting Straight is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations. Using a prophy angle, prophylaxis treatment of the surface of teeth and dental restorations.

Source page: https://510kreport.com/device/K230106
Methodology: https://510kreport.com/methodology