DENTOCROWN DWN-A1B1

GUDID 03760260222051

ITENA CLINICAL

Temporary dental crown/bridge resin
Primary Device ID03760260222051
NIH Device Record Keyde9b3e62-c63d-4a23-9e82-cd1c4d73eebd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTOCROWN
Version Model NumberA1B1
Catalog NumberDWN-A1B1
Company DUNS262150858
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
GS103760260222051 [Primary]

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-10-29
Device Publish Date2017-03-21

On-Brand Devices [DENTOCROWN ]

03760260222068A2B2
03760260222051A1B1

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