DXM CO., LTD.

Matched from indexed company URL: DXM Co., Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040821213004082121DXM CO., LTD.1N2026-01-01102-4, Sandan-gil, Hwasun-eup Hwasun-gun Jeonnam KR 411722

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
218501893242024K191221Cybird LED Curing LightEBZ2020-01-10
218501256317184K121093D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000EBZ2012-11-27
218502054196998K042703CYBIRD LED CURING LIGHTEBZ2004-10-12
218501884784695K040116HAWK INTRAORAL CAMERA AND ACCESSORIESEIA2004-04-20
218501048837684
218501137752858
218501196566604
218501522554744
218501547530748
218501682319328
218501749069666
218501751635537
218501902058101
218501932061260
218501968510373
218502017976115

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBZ32020-01-10
EIA12004-04-20

PMN#

GUDID#

EZ BITE BLOCK SOFT MOUTH PROP - Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity• Allows doctors to have an additional hand • Jagged biting surface to minimize slipping• Ideal for keeping upper and lower arch of patient's mouth during oral treatments• Enhances patient's comfort avoiding patient fatigue• Disposable, Single Use Only. Not Autoclavable.• Dual injected with silicone layer for improved comfort and stability

DXM CO., LTD

2025-12-18

EZ BITE BLOCK SOFT MOUTH PROP - Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity• Allows doctors to have an additional hand • Jagged biting surface to minimize slipping• Ideal for keeping upper and lower arch of patient's mouth during oral treatments• Enhances patient's comfort avoiding patient fatigue• Disposable, Single Use Only. Not Autoclavable.• Dual injected with silicone layer for improved comfort and stability

DXM CO., LTD

2025-12-18

EZ BITE BLOCK SOFT MOUTH PROP - Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity • Allows doctors to have an additional hand • Jagged biting surface to minimize slipping • Ideal for keeping upper and lower arch of patient's mouth during oral treatments • Enhances patient's comfort avoiding patient fatigue • Disposable, Single Use Only. Not Autoclavable. • Dual injected with silicone layer for improved comfort and stability

DXM CO., LTD

2025-12-18

EZ BITE BLOCK SOFT MOUTH PROP - Saliva Ejector Holding Disposable Mouth Prop • Hands-free saliva ejector holding feature securely grips on to the saliva ejector while maintaining open cavity • Allows doctors to have an additional hand • Jagged biting surface to minimize slipping • Ideal for keeping upper and lower arch of patient's mouth during oral treatments • Enhances patient's comfort avoiding patient fatigue • Disposable, Single Use Only. Not Autoclavable. • Dual injected with silicone layer for improved comfort and stability

DXM CO., LTD

2025-12-18

Aladdin - This visible ray curing light is a device to enhance a bleaching effect by exposing a visible ray to teeth with a bleaching agent is designed to be used in dental clinics.This device emits 440 - 50nm blue visible ray by using 3 pieces of L.E.D (Light-Emitting Diode). It is a wireless type device and is convenient to move inside of the clinic..Aladdin features are:- Easy to operate with touch switches to control the light intensity or operation time.- Easy to carry or move. Once charged, the power code is not necessary to keep plugged in during operation.- Removable parts like head, recharging unit, adapter, pole & foot.- Adjustable light intensity. Left, Center & Right LEDs have 3 grades of light intensity (High, Normal & Low).- Easy to store.

DXM CO., LTD

2023-06-20

EZ-Blade Remover - Disposable Blade Remover is a simple but efficient way to prevent cuts, scrapes, and possible infection when removing and disposing blades with no direct contact with the bladeEasily and securely remove used scalpel blades for disposal• Palm-sized round design made with rigid and durable polypropylene• User is able to safely and hygienically remove the blades with one simple pull• Store up to 100 blades• Store not only used scalpel blades but also medical needles, dermaplaning tools, dermaplaning razors, and other small blades

DXM CO., LTD

2023-06-19

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