FDA cleared the DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece from SETAGAYA SEIKI Co., Ltd. on Sep 23, 2026 under K262144, a traditional 510(k). The device falls under product code EFB, Handpiece, Air-Powered, Dental, regulated at 21 CFR 872.4200 as a Class 1 device. The review panel was Dental.
FDA logged the submission as received on Jun 25, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for SETAGAYA SEIKI Co., Ltd. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K262144?
K262144 is the FDA 510(k) for DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece, submitted by SETAGAYA SEIKI Co., Ltd.. FDA's decision date was Sep 23, 2026, under product code EFB (Handpiece, Air-Powered, Dental).
Who makes the DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece?
SETAGAYA SEIKI Co., Ltd., based in Yonezawa-City, is the applicant of record for K262144.
How long did the K262144 review take?
FDA received the submission on Jun 25, 2026 and issued its decision on Sep 23, 2026, 90 days later.