COLTOSOL F 5930 US

GUDID J0065930US0

Coltène/Whaledent AG

Zinc phosphate dental cement

• Primary Device ID: J0065930US0
• NIH Device Record Key: c8657c8a-76c0-463b-be9b-72b56d154010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLTOSOL F
• Version Model Number: 5930 US
• Catalog Number: 5930 US
• 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
• 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 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM SUNLIGHT
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J0065930US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031752

FDA Product Code

• EMA: Cement, Dental

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: 2023-07-18
• Device Publish Date: 2016-08-15

On-Brand Devices [COLTOSOL F]

• J00659460: 5946
• J00659350: 5935
• J00659300: 5930
• J00659160: 5916
• J0065930US0: 5930 US
• J00659110: 5911
• J00659060: 5906