FluoriMax Mint

GUDID 00858290006116

FluoriMax 2.5% NaF Varnish Mint Flavor flow through ampoules 70 pack

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00858290006116
• NIH Device Record Key: cc7b8058-065b-4a76-a118-bf7344914afa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax Mint
• Version Model Number: Flow Through Ampoule 70 pack
• Company DUNS: 002863526
• Company Name: ELEVATE ORAL CARE, LLC
• Device Count: 70
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Total Volume: 0.4 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006116 [Primary]
GS1	00858290006147 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131376

FDA Product Code

• LBH: Varnish, Cavity

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-01

Devices Manufactured by ELEVATE ORAL CARE, LLC

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• 00858290006888 - Advantage Arrest: 2023-07-31 Advantage Arrest, Convenience Kit
• 00858290006871 - Allday Spray/Gel Sample Bag: 2023-05-26 Dry Mouth Spray and Gel, Mint, 1.5oz Bottle and Tube, Sample Bag
• 00858290006758 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum
• 00858290006765 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint
• 00858290006772 - FluoriMax 2.5% NaF Varnish: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel
• 00858290006789 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored
• 00858290006796 - FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy: 2022-11-07 FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy