DENTOCORE DCA3-50

GUDID 03760260222044

ITENA CLINICAL

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID03760260222044
NIH Device Record Keybae67f19-6c9c-4f8c-b5fc-8cb7b8e7fc6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTOCORE
Version Model NumberCartridge A3 shade
Catalog NumberDCA3-50
Company DUNS278261221
Company NameITENA CLINICAL
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 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
GS103760260222044 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-11-10
Device Publish Date2016-10-15

On-Brand Devices [DENTOCORE ]

03760260222044Cartridge A3 shade
03760260222037Cartridge white shade
03760260222006Automix

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