Tokuyama Universal Bond

GUDID 04548190152094

Mini Kit

TOKUYAMA DENTAL CORPORATION

Dentine bonding agent/set

• Primary Device ID: 04548190152094
• NIH Device Record Key: 42977e83-191a-4460-91b6-0df34cfd79a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tokuyama Universal Bond
• Version Model Number: 15209
• Company DUNS: 693552176
• Company Name: TOKUYAMA 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: 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: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com
• Phone: 1-877-378-3548
• Email: info@tokuyama-us.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190152094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171226

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: 2019-12-25
• Device Publish Date: 2019-12-17

On-Brand Devices [Tokuyama Universal Bond]

• 04548190152186: Bond B
• 04548190152131: Bond A
• 04548190152032: Kit
• 04548190152094: Mini Kit