Simplicity Kit: Original 100-50

GUDID 00850194007534

Simplicity Kit: No Rinse Dental Adhesive System (Original)

APEX DENTAL MATERIALS INCORPORATED

Dentine bonding agent/set
Primary Device ID00850194007534
NIH Device Record Keye5ee924e-6303-4499-94b7-3e9f77d3efca
Commercial Distribution StatusIn Commercial Distribution
Brand NameSimplicity Kit: Original
Version Model Number1
Catalog Number100-50
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
GS100850194007534 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-16

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