LUXEN Zr

GUDID 08800046902045

DENTALMAX CO.,LTD

Dental appliance fabrication material, ceramic
Primary Device ID08800046902045
NIH Device Record Key6acc51de-d27b-4888-b895-54eca5f51f60
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUXEN Zr
Version Model NumberLUXEN 1100-22T-D98-MB4
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
GS108800046902045 [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 Zr]

08800046907231LUXEN 1100-30T-D95-MD4
08800046907224LUXEN 1100-25T-D95-MD4
08800046907217LUXEN 1100-22T-D95-MD4
08800046907200LUXEN 1100-18T-D95-MD4
08800046907194LUXEN 1100-16T-D95-MD4
08800046907187LUXEN 1100-14T-D95-MD4
08800046907170LUXEN 1100-12T-D95-MD4
08800046907163LUXEN 1100-30T-D95-MD3
08800046907156LUXEN 1100-25T-D95-MD3
08800046907149LUXEN 1100-22T-D95-MD3
08800046907132LUXEN 1100-18T-D95-MD3
08800046907125LUXEN 1100-16T-D95-MD3
08800046907118LUXEN 1100-14T-D95-MD3
08800046907101LUXEN 1100-12T-D95-MD3
08800046907095LUXEN 1100-30T-D95-MD2
08800046907088LUXEN 1100-25T-D95-MD2
08800046907071LUXEN 1100-22T-D95-MD2
08800046907064LUXEN 1100-18T-D95-MD2
08800046907057LUXEN 1100-16T-D95-MD2
08800046907040LUXEN 1100-14T-D95-MD2
08800046907033LUXEN 1100-12T-D95-MD2
08800046907026LUXEN 1100-30T-D95-MC4
08800046907019LUXEN 1100-25T-D95-MC4
08800046907002LUXEN 1100-22T-D95-MC4
08800046906999LUXEN 1100-18T-D95-MC4
08800046906982LUXEN 1100-16T-D95-MC4
08800046906975LUXEN 1100-14T-D95-MC4
08800046906968LUXEN 1100-12T-D95-MC4
08800046906951LUXEN 1100-25T-D95-MC3
08800046906944LUXEN 1100-25T-D95-MC3
08800046906937LUXEN 1100-22T-D95-MC3
08800046906920LUXEN 1100-18T-D95-MC3
08800046906913LUXEN 1100-16T-D95-MC3
08800046906906LUXEN 1100-14T-D95-MC3
08800046906890LUXEN 1100-12T-D95-MC3
08800046906883LUXEN 1100-30T-D95-MC2
08800046906876LUXEN 1100-25T-D95-MC2
08800046906869LUXEN 1100-22T-D95-MC2
08800046906852LUXEN 1100-18T-D95-MC2
08800046906845LUXEN 1100-16T-D95-MC2
08800046906838LUXEN 1100-14T-D95-MC2
08800046906821LUXEN 1100-12T-D95-MC2
08800046906814LUXEN 1100-30T-D95-MC1
08800046906807LUXEN 1100-25T-D95-MC1
08800046906791LUXEN 1100-22T-D95-MC1
08800046906784LUXEN 1100-18T-D95-MC1
08800046906777LUXEN 1100-16T-D95-MC1
08800046906760LUXEN 1100-14T-D95-MC1
08800046906753LUXEN 1100-12T-D95-MC1
08800046906746LUXEN 1100-30T-D95-MB4

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.