DesensiMAX 90413

GUDID 00850194007749

DesensiMAX

APEX DENTAL MATERIALS INCORPORATED

Dentine bonding agent/set
Primary Device ID00850194007749
NIH Device Record Key7611500a-dd75-44d6-b66e-32059be990c8
Commercial Distribution Discontinuation2017-11-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDesensiMAX
Version Model Number1
Catalog Number90413
Company DUNS018651672
Company NameAPEX DENTAL MATERIALS INCORPORATED
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
GS100850194007749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number4
Public Version Date2019-12-16
Device Publish Date2017-11-29

Devices Manufactured by APEX DENTAL MATERIALS INCORPORATED

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00850194007794 - Purify+ Liquid 5 Pack2019-12-23 Purify+ Liquid 5 Pack
00850194007800 - VistaCORE 5ml Syringe Shade A22019-12-23 VistaCORE 5ml Syringe Shade A2
00850194007817 - VistaCORE 5ml Syringe Shade White Opaque2019-12-23 VistaCORE 5ml Syringe Shade White Opaque
00850194007824 - VistaCORE 25ml Cartridge Shade White Opaque2019-12-23 VistaCORE 25ml Cartridge Shade White Opaque
00850194007831 - VistaCORE 25ml Cartridge Shade A22019-12-23 VistaCORE 25ml Cartridge Shade A2
00850194007848 - VistaCORE 25ml Cartridge Kit Shade A22019-12-23 VistaCORE 25ml Cartridge Kit Shade A2
00850194007855 - VistaCORE 25ml Cartridge Kit Shade White Opaque2019-12-23 VistaCORE 25ml Cartridge Kit Shade White Opaque

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