Fill-Up! 60019342

GUDID J006600193420

Coltène/Whaledent AG

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• Primary Device ID: J006600193420
• NIH Device Record Key: 04251dec-c5b1-4b4f-80b6-b27447d36e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fill-Up!
• Version Model Number: 60019342
• Catalog Number: 60019342
• 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: 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: +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
• 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
• 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	J006600193420 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150218

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2023-07-13
• Device Publish Date: 2016-08-15

On-Brand Devices [Fill-Up!]

• J006600199200: 60019920
• J006600193550: 60019355
• J006600193420: 60019342
• J006600199730: 60019973
• J006600193410: 60019341