DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece— 510(k) K262144
Substantially EquivalentSETAGAYA SEIKI Co., Ltd.
FDA 510(k) clearance K262144 for DIAMED Handpiece; DIAMED Airmotor; DIAMED Airmotor Handpiece, Substantially Equivalent on 2026-09-23. Applicant: SETAGAYA SEIKI Co., Ltd.. Device class: 1.
Summary
SETAGAYA SEIKI Co., Ltd. cleared three related dental products together: the DIAMED Handpiece, DIAMED Airmotor, and DIAMED Airmotor Handpiece. They're filed under EFB, air-powered dental handpieces.
This is a Class I device, under 21 CFR 872.4200. The Dental panel reviewed it as a Traditional 510(k).
SETAGAYA SEIKI filed from Yonezawa-City, Japan. Review took 90 days (June 25 to September 23, 2026).
Clearance details
- Device name as filed
- DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece
- Applicant
- SETAGAYA SEIKI Co., Ltd.
- Product code
- Product code EFB
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Yonezawa-City, JP
Recent devices under product code EFB
view all- K260029 — Firstar Dental Handpieces
- K251388 — Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
- K251389 — High speed air turbine handpiece
- K242179 — Synea Fusion Handpieces (Intensiv & Profin)
- K240337 — Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
Adverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.