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FDA 510(k)

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece

K-Number: K262144 · 2026-09-23

ApplicantSETAGAYA SEIKI Co., Ltd.
Decision Date2026-09-23
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is SETAGAYA SEIKI Co., Ltd.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K262144. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is SETAGAYA SEIKI Co., Ltd.. The 510(k) number is K262144.

When did DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece receive FDA 510(k) clearance?

DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece received FDA 510(k) clearance on 2026-09-23, under 510(k) number K262144.

Who is the listed applicant for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

The FDA 510(k) record lists SETAGAYA SEIKI Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?

The FDA product code for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece is EFB.

Related Devices (Code: EFB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd.K251388Dental 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)Foshan Topmed Dental Co., Ltd.K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbHK240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)Guangdong Jinme Medical Technology Co., Ltd.K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)Foshan Soco Precision Instrument Co., Ltd.K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)Nakanishi, Inc.

Official Source

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