FluoriMax 2.5% NaF Varnish

GUDID 00858290006758

FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum

ELEVATE ORAL CARE, LLC

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• Primary Device ID: 00858290006758
• NIH Device Record Key: 304dda2f-4dae-4c83-b879-77b99a26c5fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax 2.5% NaF Varnish
• Version Model Number: 6301BG101
• Company DUNS: 002863526
• Company Name: ELEVATE ORAL CARE, LLC
• Device Count: 1
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00858290006758 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-28

On-Brand Devices [FluoriMax 2.5% NaF Varnish]

• 00858290006772: FluoriMax 2.5% NaF Varnish 1 Bottle Kit Caramel
• 00858290006765: FluoriMax 2.5% NaF Varnish 1 Bottle Kit Mint
• 00858290006758: FluoriMax 2.5% NaF Varnish 1 Bottle Kit Bubble Gum