Manufacturer registered with FDA

Tochigi Seiko Co., Ltd.

Tochigi-shi, Japan. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator9001253Manufacturer

Device types listed: 1
Brands and models: 2
510(k) clearances: 0as applicant
Markets registered in: 424 registrations outside the US
Establishments: 1Japan

Registered in 4 markets

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

RegisteredHome: JapanOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Tochigi Seiko Co., Ltd.	1 device types	—	Below
South Korea	MFDS	Manufacturer	TOCHIGI SEIKO CO.,LTDTOCHIGI SEIKO CO. LTD. · TOCHIGI SEIKO CO., LTD · +2	12	2001–2012	Pure Global AI
Taiwan	TFDA	Manufacturer	TOCHIGI SEIKO CO., LTD.	10	1982–2015	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Tochigi Seiko Co., Ltd.	2	—	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 Tochigi Seiko 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 NeedleDZM · Class 1	Dental needles & syringes	Maker	Ninjection Dental NeedleSTERIJECT	2003

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

Registered establishments

Establishment	Location	What it does
TOCHIGI SEIKO CO., LTDFDA reg. 8043385	Tochigi-shi, Japan	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9001253). 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.