FluoriMax 2.5% NaF demo pack

GUDID 00858290006970

FluoriMax 2.5% NaF FMFT demo pack 4pk

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00858290006970
• NIH Device Record Key: 4348e716-e2a8-4e98-a1e3-54629a05f8b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax 2.5% NaF demo pack
• Version Model Number: 630FMFT04
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006970 [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: 2026-02-05
• Device Publish Date: 2026-01-28

On-Brand Devices [FluoriMax 2.5% NaF demo pack ]

• 00858290006307: FluoriMax 2.5% NaF FMFT demo pack
• 00858290006970: FluoriMax 2.5% NaF FMFT demo pack 4pk