Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003169405

FEI Number

3003169405

Entity Name

MONITEX INDUSTRIAL CO., LTD.

City/State/Country

SAN-CHUNG CITY Taipei, TW

Establishment Address

6F, 70 GUANG-FU RD., SEC 1,, SAN-CHUNG CITY Taipei 241-58, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MONITEX INDUSTRIAL CO., LTD. (Owner Number: 9044777)

Owner / Operator Contact Address

6F, 70 GUANG-FU RD., SEC 1,, SAN-CHUNG DIST., NEW TAIPEI CITY, TW-NOTA 241-58, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152192

PMA Number

N/A

All Registered Proprietary Names

Kerr Henry Schein Henry Schein Henry Schein Maxima Advanced 3000 LED Curing Light Henry Schein Henry Schein WE Light Class II Henry Schein Darby Henry Schein Monitex Industrial Co., Ltd GX-330 Henry Schein

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2020-02-06
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2012-01-16
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2009-09-27
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2009-09-27
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2015-03-19
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2025-04-20
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-11-21
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-11-21
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2009-07-29
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2016-04-08
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2009-06-02
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2017-04-17

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Athey Email: mathey@orangesurgical.com Phone: (407) 7564779

Related Public Records

Same Entity

MONITEX INDUSTRIAL CO., LTD.

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
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02

Similar Registrations

Registration Number	Establishment Name	Location
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012041047	JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD	Jiujiang City Jiangxi, CN
9680845	SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, MX
3008770655	BEYES DENTAL INC	Toronto Ontario, CA
1420052	BISCO, INC.	Schaumburg, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003169405. Last updated year: 2026. Please use registration number 3003169405 when referencing this establishment in official correspondence.