Bifix Temp 1055

GUDID E22110551

Bifix Temp is a dual-curing, composite-based temporary luting material.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22110551
• NIH Device Record Key: 5ac56369-3251-41f5-86b0-7bdf446f9b0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bifix Temp
• Version Model Number: 1055
• Catalog Number: 1055
• Company DUNS: 316699578
• Company Name: VOCO 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: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22110551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143212

FDA Product Code

• EMA: Cement, Dental

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: 2019-06-13
• Device Publish Date: 2019-06-05

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