VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 35 772103

GUDID D024772103

VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 35 0.5mL unit dose packages

Preventech

Dental coating, tooth-desensitizing, professional

• Primary Device ID: D024772103
• NIH Device Record Key: 68704917-4b9f-4edd-9e0e-d73c0c7f9845
• Commercial Distribution Discontinuation: 2021-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 35
• Version Model Number: 772103
• Catalog Number: 772103
• Company DUNS: 090735093
• Company Name: Preventech
• Device Count: 35
• 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	D024772103 [Primary]
HIBCC	D0247721033 [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

Devices Manufactured by Preventech

• D024772105 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772113 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Box of 100 0.5mL unit dose packages
• D024772115 - VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Bubble Gum Case of 12 Boxes of 100 ea. 0.5mL unit dose packages
• D024772145 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772153 - VELLAmini 5% Sodium Fluoride Varnish Caramel Box 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Box of 100 0.5mL unit dose packages
• D024772155 - VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Caramel Case of 12 Boxes of 100 0.5mL unit dose packages
• D024772215 - VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Spearmint Case of 12 Boxes of 35 ea. 0.5mL unit dose packages
• D024772225 - VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35: 2024-06-14 VELLAmini 5% Sodium Fluoride Varnish Strawberry Case of 12 Boxes of 35 ea. 0.5mL unit dose packages