Registered with FDA

Setagaya Seiki Co., Ltd.

yonezawa-shi, Japan. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10043790Foreign exporterRepacker / relabeler1 clearance in five years

Device types listed: 1
Brands and models: 0
510(k) clearances: 12026–2026
Markets registered in: 21 registrations outside the US
Establishments: 1Japan

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Setagaya Seiki Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: JapanOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Lister	Setagaya Seiki Co., Ltd.	1 clearances	2026–2026	Below
South Korea	MFDS	Manufacturer	Setagaya Seiki Co.,Ltd	1	2013–2013	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Setagaya Seiki Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1	Dental handpieces	Lister	—	2022

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Setagaya Seiki Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
23 Sep 2026	K262144	DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece	EFB Dental Air-Powered Handpiece

Also lists devices cleared under other names

Setagaya Seiki Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Pac-Dent International (Suzhou), Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
14 Apr 2003	K030603	PROANGLE DISPOSABLE PROPHY ANGLE	Pac-Dent International (Suzhou), Ltd.	EGS Dental Contra- and Right-Angle Attachment Handpiece

Registered establishments

Establishment	Location	What it does
Setagaya Seiki Co., Ltd.FDA reg. 3010388675	Yonezawa-shi Yamagata, Japan	Foreign exporter, Repacker / relabeler

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10043790). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.