LUXEN CL

GUDID 08800046999878

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic
Primary Device ID08800046999878
NIH Device Record Key9f84418e-f478-4a31-a71e-24a3805f2bf9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUXEN CL
Version Model NumberLuxen CL-Deep Amber 50ml
Company DUNS688528450
Company NameDENTALMAX CO.,LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800046999878 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

On-Brand Devices [LUXEN CL ]

08800046980722Luxen CL-A1D 100ml
08800046980708Luxen CL-A1D 30ml
08800046982238Luxen CL-Cervical D 50ml
08800046982221Luxen CL-Cervical D 30ml
08800046982214Luxen CL-Cervical D 10ml
08800046982207Luxen CL-Cervical C 100ml
08800046982191Luxen CL-Cervical C 50ml
08800046982184Luxen CL-Cervical C 30ml
08800046982177Luxen CL-Cervical C 10ml
08800046982160Luxen CL-Cervical B 100ml
08800046982153Luxen CL-Cervical B 50ml
08800046982146Luxen CL-Cervical B 30ml
08800046982139Luxen CL-Cervical B 10ml
08800046982122Luxen CL-Cervical A 100ml
08800046982115Luxen CL-Cervical A 50ml
08800046982108Luxen CL-Cervical A 30ml
08800046982092Luxen CL-Cervical A 10ml
08800046982085Luxen CL-White Enamel 100ml
08800046982078Luxen CL-White Enamel 50ml
08800046982061Luxen CL-White Enamel 30ml
08800046982054Luxen CL-White Enamel 10ml
08800046982047Luxen CL-White 100ml
08800046982030Luxen CL-White 50ml
08800046982023Luxen CL-White 30ml
08800046982016Luxen CL-White 10ml
08800046982009Luxen CL-Creamy White 100ml
08800046981996Luxen CL-Creamy White 50ml
08800046981989Luxen CL-Creamy White 30ml
08800046981972Luxen CL-Creamy White 10ml
08800046981965Luxen CL-White Opaque 100ml
08800046981958Luxen CL-White Opaque 50ml
08800046981941Luxen CL-White Opaque 30ml
08800046981934Luxen CL-White Opaque 10ml
08800046981927Luxen CL-Brown 100ml
08800046981910Luxen CL-Brown 50ml
08800046981903Luxen CL-Brown 30ml
08800046981897Luxen CL-Brown 10ml
08800046981880Luxen CL-Amber 100ml
08800046981873Luxen CL-Amber 50ml
08800046981866Luxen CL-Amber 30ml
08800046981859Luxen CL-Amber 10ml
08800046981842Luxen CL-Yellow 100ml
08800046981835Luxen CL-Yellow 50ml
08800046981828Luxen CL-Yellow 30ml
08800046981811Luxen CL-Yellow 10ml
08800046981804Luxen CL-Natural Gray 2 100ml
08800046981798Luxen CL-Natural Gray 2 50ml
08800046981781Luxen CL-Natural Gray 2 30ml
08800046981774Luxen CL-Natural Gray 2 10ml
08800046981767Luxen CL-Natural Gray 1 100ml

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