One Coat Bond 60011757

GUDID J006600117570

Coltène/Whaledent AG

Dentine bonding agent/set

• Primary Device ID: J006600117570
• NIH Device Record Key: 4ac93976-eca0-4394-abb2-94ca8eddd7ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Coat Bond
• Version Model Number: 60011757
• Catalog Number: 60011757
• Company DUNS: 480017482
• Company Name: Coltène/Whaledent AG
• 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: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com
• Phone: +41717575300
• Email: info.ch@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J006600117570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974906

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-08-15

On-Brand Devices [One Coat Bond]

• J00678790: 7879
• J00678730: 7873
• J006600117570: 60011757