Fixtemp C&B D60391

GUDID E239D603911

No.

Dreve Dentamid GmbH

Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: E239D603911
• NIH Device Record Key: 6305bc7e-9b0a-4ca3-96d6-97b2cb4bf04b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixtemp C&B
• Version Model Number: D60391
• Catalog Number: D60391
• Company DUNS: 388000846
• Company Name: Dreve Dentamid GmbH
• 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: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de
• Phone: +49230388070
• Email: info@dreve.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239D603911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171729

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2018-07-20
• Device Publish Date: 2018-06-19

On-Brand Devices [Fixtemp C&B]

• E239D503931: No.
• E239D603991: No.
• E239D603961: No.
• E239D603951: No.
• E239D603941: No.
• E239D6039351: No.
• E239D603931: No.
• E239D6039251: No.
• E239D603921: No.
• E239D603911: No.