Delta Zirconia Translucent Shaded

GUDID 00816795024622

98X16mm Translucent Zirconia Shade B2

AURIDENT INC

Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit
Primary Device ID00816795024622
NIH Device Record Key1e641bb1-8591-4917-8723-1eebe1874bf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelta Zirconia Translucent Shaded
Version Model NumberD816B2T
Company DUNS030580955
Company NameAURIDENT INC
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816795024622 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-04
Device Publish Date2016-10-10

On-Brand Devices [Delta Zirconia Translucent Shaded]

0081679502466098X16mm Translucent Zirconia Shade D2
0081679502465398X16mm Translucent Zirconia Shade C#
0081679502464698X16mm Translucent Zirconia Shade C2
0081679502463998X16mm Translucent Zirconia Shade B#
0081679502462298X16mm Translucent Zirconia Shade B2
0081679502461598X16mm Translucent Zirconia Shaded A3.5
0081679502460898X16mm Translucent Zirconia Shaded A3
0081679502459298X16mm Translucent Zirconia Shade A2
0081679502458598X16mm Zirconia Translucent Shade A1

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