Admira Fusion x-tra 2814

GUDID E22128141

Nanohybrid ORMOCER restorative material, 4mm.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22128141
• NIH Device Record Key: 318df4d5-dcf0-4537-ab0c-2d5273f53ace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira Fusion x-tra
• Version Model Number: 2814
• Catalog Number: 2814
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 2
• 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: true
• 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	E2212814 [Unit of Use]
HIBCC	E22128141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151956

FDA Product Code

• EBF: Material, Tooth Shade, 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: 2019-05-15
• Device Publish Date: 2019-05-07

On-Brand Devices [Admira Fusion x-tra]

• E22128151: Nanohybrid ORMOCER restorative material, 4mm.
• E22128141: Nanohybrid ORMOCER restorative material, 4mm.
• E22128111: Nanohybrid ORMOCER restorative material, 4mm.
• E22128101: Nanohybrid ORMOCER restorative material, 4mm.
• E22128081: Nanohybrid ORMOCER restorative material, 4mm.