MTA BIOSEAL MTA-BSEAL

GUDID 03760260220408

ITENA CLINICAL

Calcium hydroxide dental cement
Primary Device ID03760260220408
NIH Device Record Key0733efeb-9bb8-430c-8c97-cfabcf6517b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMTA BIOSEAL
Version Model NumberCoffret MTA BIOSEAL
Catalog NumberMTA-BSEAL
Company DUNS278261221
Company NameITENA CLINICAL
Device Count1
DM Exempttrue
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
GS103760260220408 [Primary]

FDA Product Code

KIFResin, Root Canal Filling

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-01
Device Publish Date2022-11-23

Devices Manufactured by ITENA CLINICAL

03760260220385 - MTA BIOREP 2022-12-01
03760260220392 - MTA BIOREP 2022-12-01
03760260220408 - MTA BIOSEAL2022-12-01
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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