Vivera™ 4D Retainers

GUDID 00816063022107

The Vivera 4D Retainers consists of a series of doctor prescribed, thin, clear, plastic removable orthodontic retainers that maintain and prevent movement of patient's dentition.

Align Technology, Inc.

Orthodontic retainer

• Primary Device ID: 00816063022107
• NIH Device Record Key: 064bc74f-acf6-44d3-b3cd-0e4ca90acac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivera™ 4D Retainers
• Version Model Number: 9039
• Company DUNS: 013831768
• Company Name: Align Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816063022107 [Primary]

FDA Product Code

• DYT: Maintainer, Space Preformed, Orthodontic

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: 2023-08-01
• Device Publish Date: 2023-07-24

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• 00816063021483 - iTero Lumina 25 Disposable Sleeves Box: 2024-02-09 Disposable single use sleeves box
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