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

Devices Manufactured by Align Technology, Inc.

• 00816063021377 - Invisalign Go Express: 2025-09-23 Aligner
• 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.
• 00816063023067 - iTero Lumina Pro: 2025-03-14 iTero Lumina Pro Software
• 00816063022800 - Invisalign Pre-Formed Attachment System: 2025-03-10 The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attach
• 00816063022213 - iTero Lumina Pro: 2024-11-27 iTero Lumina Pro US Cart Configuration
• 00816063022237 - iTero Lumina Pro Mobile: 2024-11-27 iTero Lumina Pro US Mobile Configuration
• 00816063022268 - iTero Lumina Pro intraoral scanning unit: 2024-11-27 iTero Lumina Pro Scanning Unit, RMA Package US
• 00816063022329 - iTero Lumina Pro DOA: 2024-11-27 iTero Lumina Pro US DOA Kit cart