BEAUTIBOND XTREME Y2448

GUDID 04548162305060

BEAUTIBOND XTREME SET BOTTLE

SHOFU DENTAL CORPORATION

Dentine bonding agent/set

• Primary Device ID: 04548162305060
• NIH Device Record Key: 182e246f-3ac7-4422-8744-211762e76682
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIBOND XTREME
• Version Model Number: Y2448
• Catalog Number: Y2448
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com
• Phone: +1(760) 736-3277
• Email: customer-service@shofu.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548162305060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213965

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 2023-11-14
• Device Publish Date: 2023-11-06

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• 04548162305077: BEAUTIBOND XTREME 5ML BOTTLE
• 04548162305060: BEAUTIBOND XTREME SET BOTTLE
• 84548162298726: BEAUTIBOND XTREME UNIT DOSE SET 50 AMPULES
• E235BBXS50: BEAUTIBOND EXTREME SAMPLE KIT