FDA.reportPublic FDA data

Vivera™ 4D Retainers

Primary DI
00816063022107
Brand
Vivera™ 4D Retainers
Company
Align Technology, Inc.
Model
9039
Device description
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.
Published
2023-07-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816063022107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816063022107008160630221078160630221070816063022107

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
013831768
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816063022169Attachment Template1000122023-07-24
00816063023180Invisalign ART90502026-02-25
00816063023777Invisalign Specifix Attachment System50352026-02-09
00816063023784lnvisalign Specifix Attachment System (include Engagement Features)50362026-02-09
00816063023760Gumlines2267972026-01-01
00816063023173iTero Lumina – PC cfg, Interface Box2176222025-09-16
00816063023197iTero Lumina Software2259692025-09-16
00816063023210iTero Lumina – PC cfg2231122025-09-16
00816063023227iTero Lumina – PC cfg2231102025-09-16
00816063023241iTero Lumina – PC cfg2231112025-09-16
00816063023289iTero Lumina – PC cfg2231662025-09-16
00816063023296iTero Lumina – PC cfg2231142025-09-16
00816063021377Invisalign Go Express90332025-09-15
00816063022077Invisalign™ Ultrasonic Cleaning Station2182772023-07-25
00816063021407Cleaning Crystals, Packette201272022-12-06
00816063021360ClinCheckSW-00001592022-02-17
00816063020233NuMe90052017-06-02
00816063020004Invisalign Full85002016-09-24
00816063020011Invisalign10112016-09-24
00816063020035Invisalign Teen85062016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906154840993e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841006e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841013e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841020e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841037e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841044e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841051e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841068e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841075e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841082e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841099e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841105e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841112e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841129e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841136e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841143e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841150e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841167e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841174e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841181e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841198e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841204e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841211e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841228e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841235e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841242e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841259e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841266e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841273e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841280e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26