Tokuyama Universal Bond II

GUDID 04548190153107

Kit

TOKUYAMA DENTAL CORPORATION

Dentine bonding agent/set

• Primary Device ID: 04548190153107
• NIH Device Record Key: 03edf536-61f9-46cd-a9b4-abfe25583e79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tokuyama Universal Bond II
• Version Model Number: 15310
• 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
• 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 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548190153107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203760

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: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [Tokuyama Universal Bond II]

• 04548190153299: Sample Kit
• 04548190153206: Bond B
• 04548190153152: Bond A
• 04548190153107: Kit