Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004082121

FEI Number

3004082121

Entity Name

DXM CO., LTD.

City/State/Country

Hwasun-gun Jeonnam, KR

Establishment Address

102-4, Sandan-gil, Hwasun-eup, Hwasun-gun Jeonnam 411722, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DXM CO., LTD. (Owner Number: 9057162)

Owner / Operator Contact Address

102-4, Sandan-gil, Hwasun-eup,, Hwasun-gun, KR-46 58141, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

D1 Cybird LED Curing Light D1-CL Cybird XD Cybird Gold Cybird Ultra ALADDIN MISO DXM BENDABLE/PRE-BEND NEEDLE TIP EZ-Bite Block, Disposable Mouth Prop Coltolux LED 2 Cybird WPT LED Curing Light MULTIPLE names and models D6 D1 LED Curing Light SPEC 3 LED 3000 DX-MIXER MIXING TIPS FOR SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL EZ VPS Connector Blade-Safe Scalpel Blade Remover EZ-Blade Remover DX-Ultra Ultrasonic Endo Activate Device Hawk Intraoral Camera and Accessories Gutta Easy Friendo Endopex DX-Condenser Multiple names DXPA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2007-11-26
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2006-05-19
DZM	Needle, Dental	Dental	Class 1	872.4730	2007-08-14
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2022-08-11
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2020-01-15
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2012-04-19
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2015-07-07
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2014-05-30
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2022-09-13
JET	Pick, Massaging	Dental	Class 1	872.6650	2025-06-26
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-11-26
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2008-08-28
EHA	Aligner, Beam, X-Ray	Dental	Class 1	872.1820	2009-11-24

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

DXM 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
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417

Similar Registrations

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3005665377	KULZER GMBH	HANAU Hesse, DE
3030126955	ONVET MEDICAL CANADA INC	TORONTO Ontario, CA
1419489	NORDENT MFG., INC.	ELK GROVE VILLAGE, IL, US
3007007357	Handpiece Headquarters	Placentia, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004082121. Last updated year: 2026. Please use registration number 3004082121 when referencing this establishment in official correspondence.