Vivera™ 3D retainers

GUDID 00816063022923

Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition.

Align Technology, Inc.

Orthodontic retainer

• Primary Device ID: 00816063022923
• NIH Device Record Key: bf00df22-b51e-4163-b0b5-53a04a21e880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivera™ 3D retainers
• Version Model Number: 5016
• 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: true
• 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	00816063022923 [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: 2025-04-23
• Device Publish Date: 2025-04-15

Devices Manufactured by Align Technology, Inc.

• 00816063022923 - Vivera™ 3D retainers: 2025-04-23Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition.
• 00816063022923 - Vivera™ 3D retainers: 2025-04-23 Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition.
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• 00816063022428 - iTero Lumina Pro Upgrade: 2024-11-27 iTero Lumina Pro US Cart upgrade from Element Plus