SILANEA SILSER1.2-5

GUDID 03760260223072

ITENA CLINICAL

Dentine bonding agent/set
Primary Device ID03760260223072
NIH Device Record Keyd6c04a6f-8cca-455d-bffe-c6bd44e704f2
Commercial Distribution Discontinuation2021-04-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSILANEA
Version Model NumberSILSER1.2-5
Catalog NumberSILSER1.2-5
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
GS103760260223072 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-10-19
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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