Admira Fusion x-base 2812

GUDID E22128121

VOCO GmbH

Dental composite resin

• Primary Device ID: E22128121
• NIH Device Record Key: a1015612-9811-4ad7-a52e-1672e3344f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Admira Fusion x-base
• Version Model Number: 2812
• Catalog Number: 2812
• 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: 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	E22128120 [Unit of Use]
HIBCC	E22128121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170896

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-05

On-Brand Devices [Admira Fusion x-base]

• E22128361: 2836
• E2212836: 2836
• E22128131: 2813
• E22128121: 2812