# K262144: DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: SETAGAYA SEIKI Co., Ltd.
- Decided: Sep 23, 2026 after 90 days
- Product code: EFB (Handpiece, Air-Powered, 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: 5 generations back to K935676 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073652: ND Low Speed Airmotor and Handpiece,  Highspeed Airturbine Handpiece, E-Type Straight Nosecone and Contra Angle, Nakamura Magnifier Co., Ltd. (2008) Summary page 5.
- K141886: MDK Handpieces, Modern Korea Co., Ltd. (2015) Summary page 5.

## Indications for use
DIAMED Handpiece is intended for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable. DIAMED Airmotor is used to power various attachments which helps dental clinician perform various dental procedures. All the devices are autoclavable. DIAMED Airmotor Handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations, polishing teeth, and hygiene dentistry work. All the devices are autoclavable.

Source page: https://510kreport.com/device/K262144
Methodology: https://510kreport.com/methodology