Advantage Arrest 635000100

GUDID 00858290006000

Advantage Arrest Silver Diamine Fluoride 38% 8 ml dropper bottle.

ELEVATE ORAL CARE, LLC

Dental coating, tooth-desensitizing

• Primary Device ID: 00858290006000
• NIH Device Record Key: 92423745-8f5e-4514-9bbb-18df57a33c93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advantage Arrest
• Version Model Number: 8ml Bottle
• Catalog Number: 635000100
• 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: 877-866-9113
• Email: info@elevateoralcare.com

Device Dimensions

• Total Volume: 8 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858290006000 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-26

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