FluoriMax 2.5% NaF Varnish 12ML Bottle 2pk BG

GUDID 00858290006093

FluoriMax 2.5% NaF Varnish 12ML Bottle 2pk BG

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing
Primary Device ID00858290006093
NIH Device Record Key1ce2148c-1ba5-4794-9d96-b58cbebc6df6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFluoriMax 2.5% NaF Varnish 12ML Bottle 2pk BG
Version Model Number630000201
Company DUNS002863526
Company NameELEVATE ORAL CARE, LLC
Device Count2
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

Customer Support Contacts

Phone877-866-9113
Emailinfo@elevateoralcare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858290006093 [Primary]
GS100858290006192 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2017-05-10

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00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored
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