Advantage Arrest

GUDID 00858290006604

Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle-3 pack

ELEVATE ORAL CARE, LLC

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• Primary Device ID: 00858290006604
• NIH Device Record Key: e8e11c6f-067a-4bfa-914f-59f2dd35a790
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Arrest
• Version Model Number: 3 ml bottle-3 pk
• 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: false
• 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: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com
• Phone: 8778669113
• Email: info@elevateoralcare.com

Device Dimensions

• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter
• Total Volume: 3 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102973

FDA Product Code

• PHR: Diammine Silver Fluoride Dental Hypersensitivity Varnish

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: 2020-12-29
• Device Publish Date: 2020-12-21

On-Brand Devices [Advantage Arrest ]

• 00858290006130: Advantage Arrest Silver Diamine Fluoride 38% Unit Dose Ampoule with applicators 30pk
• 00858290006000: Advantage Arrest Silver Diamine Fluoride 38% 8 ml dropper bottle.
• 00858290006161: Advantage Arrest Silver Diamine Fluoride 38% 50 pk ampoule
• 00858290006611: Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle
• 00858290006604: Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle-3 pack
• 00858290006888: Advantage Arrest, Convenience Kit