DENTOCEM DCA-2.5

GUDID 03760260221054

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 ID03760260221054
NIH Device Record Key77f97c27-c8ed-434f-8069-9840a206286a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTOCEM
Version Model NumberDCA-2.5
Catalog NumberDCA-2.5
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
GS103760260221054 [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 Date2016-10-15

Devices Manufactured by ITENA CLINICAL

03760260220385 - MTA BIOREP 2022-12-01
03760260220392 - MTA BIOREP 2022-12-01
03760260220408 - MTA BIOSEAL2022-12-01
03760260220002 - REFLECTYS2022-11-10
03760260220019 - REFLECTYS2022-11-10
03760260220026 - REFLECTYS2022-11-10
03760260220033 - REFLECTYS2022-11-10
03760260220040 - REFLECTYS2022-11-10

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