V-Force Twin Kit Self Etch Dental Adhesive System

GUDID 00850194007923

V-Force Twin Kit Self Etch Dental Adhesive System

APEX DENTAL MATERIALS INCORPORATED

Dentine bonding agent/set
Primary Device ID00850194007923
NIH Device Record Key64780a58-a0f8-4fbe-834f-d2c6dc15a1de
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-Force Twin Kit Self Etch Dental Adhesive System
Version Model Number1
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
GS100850194007923 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

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