Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008787992

FEI Number

3008787992

Entity Name

TOSOH CERAMICS CO., LTD.

City/State/Country

TOYAMA-SHI, JP

Establishment Address

2, IWASEKOSHIMACHI, TOYAMA-SHI 931-8371, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TOSOH Corporation (Owner Number: 10056996)

Owner / Operator Contact Address

Shiba-koen Frist Building, 3-8-2, Shiba, Minato-ku, JP-13 105-8623, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2018-02-07

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

TOSOH Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16

Similar Registrations

Registration Number	Establishment Name	Location
3009011037	MEM DENTAL TECHNOLOGY CO LTD	Tainan, TW
2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
3027460334	LightForce Orthodontics	Wilmington, MA, US
3016543896	CSY INTERNATIONAL LLC	Rancho Cucamonga, CA, US
1000118628	FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.	Denton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008787992. Last updated year: 2026. Please use registration number 3008787992 when referencing this establishment in official correspondence.