Zirconia Block

GUDID 06970402675028

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Dental appliance fabrication material, ceramic
Primary Device ID06970402675028
NIH Device Record Keybcf8eb2a-36fa-4151-9949-86c15e9f2237
Commercial Distribution StatusIn Commercial Distribution
Brand NameZirconia Block
Version Model NumberMHT
Company DUNS528184691
Company NameSHANDONG HUGE DENTAL MATERIAL CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS106970402675028 [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 Date2018-09-10
Device Publish Date2018-08-10

On-Brand Devices [Zirconia Block]

06970402675035MAT
06970402675028MHT
06970402675011AT
06970402675004HT
06970402674991HS
06970402670306Multi-layered High Translucency (MHT)
06970402670238Multi-layered High Translucency (ML)
06970402670221Super Translucency (ST)
06970402670207Anterior Translucency (AT)
06970402670191High Strength (HS)
06970402670184High Translucency ( HT)

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