FluoriMax Cotton Candy 630007022

GUDID 00858290006734

FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 00858290006734
• NIH Device Record Key: 9887a476-4968-4322-a44b-e7826c014c51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FluoriMax Cotton Candy
• Version Model Number: Flow Through Ampoule 70 pack
• Catalog Number: 630007022
• 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
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter
• Total Volume: 0.4 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006734 [Primary]
GS1	00858290006925 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-20
• Device Publish Date: 2024-12-12

Devices Manufactured by ELEVATE ORAL CARE, LLC

• 00858290006826 - Advantage Arrest: 2025-07-29 Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 50pk Spanish
• 00858290006956 - Advantage Arrest: 2025-06-19 Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit
• 00858290006734 - FluoriMax Cotton Candy: 2024-12-20FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack
• 00858290006734 - FluoriMax Cotton Candy: 2024-12-20 FluoriMax 2.5% NaF Varnish Cotton Candy Flavor flow through ampoules 70 pack
• 00858290006918 - Papacarie: 2024-12-20 Papacarie Kit - 1 ml syringe
• 00858290006932 - Povi-One: 2024-12-20 Povi-One/FluoriMax Varnish BG Convenience Bottle Kit - 8ml bottle
• 00858290006598 - DenteShield Sample Opaque with Fluoride: 2024-12-03 DenteShield Sample Opaque with Fluoride
• 00858290006895 - Povi-One: 2023-10-05 Povi-One Unit Dose, .45ml, Demo 2pk
• 00858290006888 - Advantage Arrest: 2023-07-31 Advantage Arrest, Convenience Kit