LUXEN Smile

GUDID 08800046908252

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic
Primary Device ID08800046908252
NIH Device Record Keyafc5bf91-e559-4591-a77a-94df10c3a713
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUXEN Smile
Version Model NumberLUXEN Smile-16T-D95-MA4
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800046908252 [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 Date2019-05-16
Device Publish Date2019-05-08

On-Brand Devices [LUXEN Smile]

08800046909976Galaxy Clear 95 MD3-30T
08800046909969Galaxy Clear 95 MD3-25T
08800046909952Galaxy Clear 95 MD3-22T
08800046909945Galaxy Clear 95 MD3-18T
08800046909938Galaxy Clear 95 MD3-16T
08800046909921Galaxy Clear 95 MD3-14T
08800046909914Galaxy Clear 95 MD3-12T
08800046909907Galaxy Clear 95 MD2-30T
08800046909891Galaxy Clear 95 MD2-25T
08800046909884Galaxy Clear 95 MD2-22T
08800046909877Galaxy Clear 95 MD2-18T
08800046909860Galaxy Clear 95 MD2-16T
08800046909853Galaxy Clear 95 MD2-14T
08800046909846Galaxy Clear 95 MD2-12T
08800046909839Galaxy Clear 95 MC3-30T
08800046909822Galaxy Clear 95 MC3-25T
08800046909815Galaxy Clear 95 MC3-22T
08800046909808Galaxy Clear 95 MC3-18T
08800046909792Galaxy Clear 95 MC3-16T
08800046909785Galaxy Clear 95 MC3-14T
08800046909778Galaxy Clear 95 MC3-12T
08800046909761Galaxy Clear 95 MC2-30T
08800046909754Galaxy Clear 95 MC2-25T
08800046909747Galaxy Clear 95 MC2-22T
08800046909730Galaxy Clear 95 MC2-18T
08800046909723Galaxy Clear 95 MC2-16T
08800046909716Galaxy Clear 95 MC2-14T
08800046909709Galaxy Clear 95 MC2-12T
08800046909693Galaxy Clear 95 MC1-30T
08800046909686Galaxy Clear 95 MC1-25T
08800046909679Galaxy Clear 95 MC1-22T
08800046909662Galaxy Clear 95 MC1-18T
08800046909655Galaxy Clear 95 MC1-16T
08800046909648Galaxy Clear 95 MC1-14T
08800046909631Galaxy Clear 95 MC1-12T
08800046909624LUXEN Smile-30T-D95-MB4
08800046909617LUXEN Smile-25T-D95-MB4
08800046909600LUXEN Smile-22T-D95-MB4
08800046909594LUXEN Smile-18T-D95-MB4
08800046909587LUXEN Smile-16T-D95-MB4
08800046909570LUXEN Smile-14T-D95-MB4
08800046909563LUXEN Smile-12T-D95-MB4
08800046909556Galaxy Clear 95 MB3-30T
08800046909549Galaxy Clear 95 MB3-25T
08800046909532Galaxy Clear 95 MB3-22T
08800046909525Galaxy Clear 95 MB3-18T
08800046909518Galaxy Clear 95 MB3-16T
08800046909501Galaxy Clear 95 MB3-14T
08800046909495Galaxy Clear 95 MB3-12T
08800046909488Galaxy Clear 95 MB2-30T

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