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.
| 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 |
| 00816063022428 - iTero Lumina Pro Upgrade | 2024-11-27 iTero Lumina Pro US Cart upgrade from Element Plus |
| 00816063022442 - iTero Lumina Pro Mobile Upgrade | 2024-11-27 iTero Lumina Pro US Mobile upgrade from Element Plus |
| 00816063022466 - iTero Lumina Pro Upgrade | 2024-11-27 iTero Lumina Pro US upgrade from Lumina |
| 00816063022589 - iTero Lumina Pro Wand Barrier Sleeves | 2024-11-27 20 Barrier Sleeves, Lumina |
Trademark Results [Vivera]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVERA 88620631 not registered Live/Pending |
Ealai, Inc. 2019-09-17 |
 VIVERA 88410842 5913775 Live/Registered |
Vivera Pharmaceuticals Inc 2019-05-01 |
 VIVERA 87821970 not registered Dead/Abandoned |
Brown Family Holdings, LLC 2018-03-06 |
 VIVERA 87741801 not registered Dead/Abandoned |
Vivera Pharmaceuticals 2018-01-03 |
 VIVERA 79310417 not registered Live/Pending |
Vivera B.V. 2021-03-18 |
 VIVERA 79283157 not registered Live/Pending |
Vivera B.V. 2020-02-03 |
 VIVERA 79101614 not registered Dead/Abandoned |
VIVERA SOCIETA' CONSORTILE A R.L. 2011-06-24 |
 VIVERA 78459496 3049414 Dead/Cancelled |
Hewlett-Packard Development Company, L.P. 2004-07-30 |
 VIVERA 78097541 not registered Dead/Abandoned |
Bayer Corporation 2001-12-10 |
 VIVERA 78097540 not registered Dead/Abandoned |
Bayer Corporation 2001-12-10 |
 VIVERA 77358597 not registered Dead/Abandoned |
Align Technology, Inc. 2007-12-21 |
 VIVERA 77358530 3589875 Live/Registered |
Align Technology, Inc. 2007-12-21 |
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