BEAUTIBOND UNIVERSAL Y2440

GUDID E235Y24400

BEAUTIBOND UNIVERSAL ADHESIVE 6 ML

SHOFU DENTAL CORPORATION

Dentine bonding agent/set

• Primary Device ID: E235Y24400
• NIH Device Record Key: eb7d9e73-91b3-4361-9e44-01342e3ababe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIBOND UNIVERSAL
• Version Model Number: Y2440
• Catalog Number: Y2440
• Company DUNS: 054618202
• Company Name: SHOFU DENTAL CORPORATION
• 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: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com
• Phone: 800-827-4923
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E235Y24400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172530

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2021-02-11
• Device Publish Date: 2021-02-03

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