Amaris 1937

GUDID E22119371

Highly aesthetic light-curing restorrative material. Two simple steps, perfect result. Layering like in nature: shades are created from the inside of the tooth. Simple and precise shade match. Natural shade transitions automatically. Long resistance to ambient and chair light. Natural fluorescence and high colour stability.

VOCO GmbH

Dental composite resin

• Primary Device ID: E22119371
• NIH Device Record Key: 962855fa-8916-4422-b99c-4534681960ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amaris
• Version Model Number: 1937
• Catalog Number: 1937
• 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	E22119371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071386

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: 2016-08-31

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