Profluorid L 1590

GUDID E22115901

Fluoride varnish for the treatment of hypersensitivity

VOCO GmbH

Dental coating, tooth-desensitizing

• Primary Device ID: E22115901
• NIH Device Record Key: ba9c3035-8d15-4d57-abfd-9e6177641538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Profluorid L
• Version Model Number: 1590
• Catalog Number: 1590
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 50
• 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: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22115900 [Unit of Use]
HIBCC	E22115901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083036

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: 2016-08-31

On-Brand Devices [Profluorid L]

• E22115921: Fluoride varnish for the treatment of dental hypersensitibity
• E22115911: Fluoride varnish for the treatment of hypersensitivity
• E22115901: Fluoride varnish for the treatment of hypersensitivity
• E2211593: Fluoride varnish for the treatment of hypersensitivity/ sample SD
• E22115931: Fluoride varnish for the treatment of hypersensitivity/ sample SD