# K251407: Motor Handpiece and Control Unit (SDI10)

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Jan 30, 2026 after 269 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 K964860 (1997). 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)
- K201191: Elec-Led, Micro-Nx Co., Ltd. (2022) Summary page 6.

## Indications for use
SDI 10 is intended for use in dentistry for restoration , prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.

Source page: https://510kreport.com/device/K251407
Methodology: https://510kreport.com/methodology