DENTOTEMP ECHDTP

GUDID 03760260221184

ITENA CLINICAL

Dental composite resin
Primary Device ID03760260221184
NIH Device Record Key13cfe4b4-c2e0-4b01-aa28-529526c7cd42
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTOTEMP
Version Model Numberautomix
Catalog NumberECHDTP
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
GS103760260221184 [Primary]

FDA Product Code

EMACement, Dental

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 Date2017-10-31

On-Brand Devices [DENTOTEMP]

03760260221184automix
03760260221023automix syringe IntroKit

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