FluoriMax 2.5% NaF Varnish Flow Through

GUDID 00858290006222

FluoriMax 2.5% NaF Varnish Flow Through Salted Caramel Foil Pk

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00858290006222
• NIH Device Record Key: c98db9b4-71b5-4d63-b8b4-501c92f1f37e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax 2.5% NaF Varnish Flow Through
• Version Model Number: 530CMV118
• 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

Customer Support Contacts

• Phone: 877-866-9113
• Email: info@elevateoralcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006222 [Primary]
GS1	00858290006239 [Package]; Package: Kit [70 Units]; In Commercial Distribution

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: 2017-09-15

On-Brand Devices [FluoriMax 2.5% NaF Varnish Flow Through]

• 00858290006222: FluoriMax 2.5% NaF Varnish Flow Through Salted Caramel Foil Pk
• 00858290006154: FluoriMax 2.5% NaF Varnish Flow Through BG Foil Pk