Bifix Hybrid Abutment Cement 2413

GUDID E22124131

Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system for the permanent cementation of abutment crowns and mesostructures made of metal, ceramics or polymers (composite or PMMA) on prefabricated adhesive/titanium bases (extraoral use), customized abutments made of titanium or zirconium dioxide or dental hard tissue (combination solutions). 10g QM syringe translucent

VOCO GmbH

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• Primary Device ID: E22124131
• NIH Device Record Key: eadbf9a2-b737-4e20-83d7-d37f3f34cd5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bifix Hybrid Abutment Cement
• Version Model Number: 2413
• Catalog Number: 2413
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22124131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220640

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: 2022-09-06
• Device Publish Date: 2022-08-29

On-Brand Devices [Bifix Hybrid Abutment Cement]

• E22129951: Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system fo
• E22124131: Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system fo
• E22124121: Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system fo
• E22124111: Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system fo
• E22124101: Bifix Hybrid Abutment Cement is a radiopaque, composite-based, dual-curing cementation system fo