Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010342

FEI Number

3002853098

Entity Name

TOMY, INC.

City/State/Country

Iwaki City Fukushima, JP

Establishment Address

100-1 Bessho, Jobanfujiwaramachi, Iwaki City Fukushima 972-8326, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOMY, INC. (Owner Number: 8010342)

Owner / Operator Contact Address

Tenko Blg. 3-16-7, Midoricho, Fuchu City, JP-13 183-0006, 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
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	1978-03-01
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2016-09-09
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2018-12-25
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2013-01-28
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	1978-03-01
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2013-01-28
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2013-01-28
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	1978-03-01
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2013-01-28
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2013-01-28

Official Correspondent

Kenji Nagase

US Agent Details

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

Related Public Records

Same Entity

TOMY, INC.

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Similar Registrations

Registration Number	Establishment Name	Location
3006707038	MYOFUNCTIONAL RESEARCH CORP. PTY. LTD.	HELENSVALE Queensland, AU
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
1526352	SUMMIT ORTHODONTIC SERVICES, INC.	Schaumburg, IL, US
3014425175	Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, MX
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010342. Last updated year: 2026. Please use registration number 8010342 when referencing this establishment in official correspondence.