Wonderful Dental

GUDID 00850006606146

Strawberry Fluoride Varnish 0.4mL Unidose 100 pack

Roses and Rubies, LLC

Dental cavity varnish

• Primary Device ID: 00850006606146
• NIH Device Record Key: 14f44759-ebd9-4cb6-9355-b9313a7c2bba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wonderful Dental
• Version Model Number: FL01021100
• Company DUNS: 114844746
• Company Name: Roses and Rubies, LLC
• Device Count: 100
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co
• Phone: 1-866-920-4561
• Email: david@wonderfuldental.co

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006606146 [Unit of Use]
GS1	00850006606153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192381

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: 2021-08-16
• Device Publish Date: 2021-08-06

On-Brand Devices [Wonderful Dental]

• 00850006606092: Bubblegum Fluoride Varnish 0.4mL cups 100 pack
• 00850006606009: Marshmallow Fluoride Varnish 0.4 mL cups 100 pack
• 00850006606122: Strawberry Fluoride Varnish 0.4mL cups 100 pack
• 00850006606115: Mint Fluoride Varnish 0.4mL cups 100 pack
• 00850006606146: Strawberry Fluoride Varnish 0.4mL Unidose 100 pack
• 00850006606108: Chocolate Fluoride Varnish 0.4mL cups 100 pack
• 00850006606139: Bubblegum Fluoride Varnish 0.4mL Unidose 100 pack
• 00850006606085: Marshmallow Fluoride Varnish 0.4 mL Unidose 100 pack
• 00850006606078: Mint Fluoride Varnish 0.4 mL Unidose 100 packs
• 00850006606061: Chocolate Fluoride Varnish 0.4 mL Unidose 100 pack
• 00850006606504: S'mores Fluoride Varnish 0.4mL cups 100 pack
• 00850006606467: Mint Fluoride Varnish 0.4mL cups 100 pack
• 00850006606429: Chocolate Fluoride Varnish 0.4mL cups 100 pack
• 00850006606382: Marshmallow Fluoride Varnish 0.4 mL cups 100 pack
• 00850006606344: Strawberry Fluoride Varnish 0.4mL cups 100 pack
• 00850006606306: Bubblegum Fluoride Varnish 0.4mL cups 100 pack
• 00850006606498: S'mores Fluoride Varnish 0.4mL Unidose 100 pack