Clearance Summary
DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece received FDA 510(k) clearance under submission number K262144, sponsored by SETAGAYA SEIKI Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2026-09-23.
- Submission: K262144
- Applicant / Sponsor: SETAGAYA SEIKI Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2026-09-23
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.