VELLAmini 5% Sodium Fluoride Varnish Melon Box 100 772283

GUDID D024772283

VELLAmini 5% Sodium Fluoride Varnish Melon Box of 100 0.5mL unit dose packages

Preventech

Dental coating, tooth-desensitizing, professional

• Primary Device ID: D024772283
• NIH Device Record Key: 1bd49a79-4848-4642-987d-91a2aede245f
• Commercial Distribution Discontinuation: 2021-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VELLAmini 5% Sodium Fluoride Varnish Melon Box 100
• Version Model Number: 772283
• Catalog Number: 772283
• Company DUNS: 090735093
• Company Name: Preventech
• 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: false
• 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: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com
• Phone: 704-849-2416
• Email: customerservice@preventech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D024772283 [Primary]
HIBCC	D0247722833 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140350

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: 5
• Public Version Date: 2024-06-13
• Device Publish Date: 2016-10-05

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