BEAUTIBOND XTREME Y2704

GUDID 04548162305084

BEAUTIBOND XTREME 2ML BOTTLE SAMPLE

SHOFU DENTAL CORPORATION

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set

• Primary Device ID: 04548162305084
• NIH Device Record Key: ecceee49-c3e9-412a-9160-e2e007a866eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEAUTIBOND XTREME
• Version Model Number: Y2704
• Catalog Number: Y2704
• 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	04548162305084 [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

On-Brand Devices [BEAUTIBOND XTREME]

• E235Y27040: BEAUTIBOND XTREME 2ML BOTTLE SAMPLE
• E235Y27020: BEAUTIBOND XTREME UNIT DOSE SET 50 AMPULES
• E235Y24490: BEAUTIBOND XTREME 5ML BOTTLE
• E235Y24480: BEAUTIBOND XTREME SET BOTTLE
• 04548162305084: BEAUTIBOND XTREME 2ML BOTTLE SAMPLE
• 04548162305077: BEAUTIBOND XTREME 5ML BOTTLE
• 04548162305060: BEAUTIBOND XTREME SET BOTTLE
• 84548162298726: BEAUTIBOND XTREME UNIT DOSE SET 50 AMPULES
• E235BBXS50: BEAUTIBOND EXTREME SAMPLE KIT