Clean & Boost Gel 5 Pack 135-02

GUDID 00850194007312

Clean & Boost Gel 5 Pack

APEX DENTAL MATERIALS INCORPORATED

Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution Dental tooth-cleaning solution
Primary Device ID00850194007312
NIH Device Record Keyb420c909-d805-4860-92d4-e45de61e4d77
Commercial Distribution StatusIn Commercial Distribution
Brand NameClean & Boost Gel 5 Pack
Version Model Number1
Catalog Number135-02
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
GS100850194007312 [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 Date2018-10-05
Device Publish Date2016-06-16

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