Tokuyama Universal Bond II

GUDID 04548190153206

Bond B

TOKUYAMA DENTAL CORPORATION

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• Primary Device ID: 04548190153206
• NIH Device Record Key: c7fe7327-7597-4b7c-aa92-f5ec690fec93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tokuyama Universal Bond II
• Version Model Number: 15320
• 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: 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: 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	04548190153206 [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