FluoriMax Salted Caramel 530CM1018

GUDID 00858290006215

FluoriMax 2.5% NaF Varnish Salted CARAMEL Flavor Labeled Bottle

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00858290006215
• NIH Device Record Key: a2e348b3-c38e-445d-9a33-b4d41ce59d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax Salted Caramel
• Version Model Number: 530MT1018
• Catalog Number: 530CM1018
• 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 Dimensions

• Total Volume: 12 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006215 [Primary]
GS1	00858290006246 [Package]; Package: Kit [2 Units]; In Commercial Distribution
GS1	00858290006253 [Package]; Package: Kit [5 Units]; In Commercial Distribution
GS1	00858290006260 [Package]; Package: Kit [1 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: 2017-09-16

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• 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