Bifix Hybrid Abutment Cement 2412

GUDID E22124121

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 white HO

VOCO GmbH

Dental composite resin

• Primary Device ID: E22124121
• NIH Device Record Key: f75d7d16-0d93-42b0-95d1-1a01ba476e9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bifix Hybrid Abutment Cement
• Version Model Number: 2412
• Catalog Number: 2412
• 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	E22124121 [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