Align Technology, Inc.

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Invisalign Specifix Attachment System

  2025-10-09

  Align Technology, Inc.

• iTero Lumina? Pro

  2024-08-16

  Align Technology , Ltd.

• Invisalign System

  2024-06-18

  Align Technology, Inc.

• Invisalign Palatal Expander System

  2023-12-15

  Align Technology, Inc.

• Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

  2023-09-26

  Align Technology, Inc.

• Invisalign System, Pre-Formed Attachment System

  2022-12-22

  Align Technology, Inc.

• Invisalign System

  2022-04-07

  Align Technology, Inc.

• ITero Element 5D

  2020-03-20

  Align Technology, Inc.

• Invisalign System With Mandibular Advancement Feature

  2018-10-26

  Align Technology, Inc.

• Invisalign System

  2015-11-18

  ALIGN TECHNOLOGY, INC.

• INVISALIGN SYSTEM

  2008-12-17

  ALIGN TECHNOLOGY

• ALIGN SYSTEM

  1998-09-08

  ALIGN TECHNOLOGY

GUDID#

• iTero Lumina Pro DOA - 221959

  Align Technology, Inc.

  2026-06-25

• iTero Element 5D scanning unit, service - 206955

  Align Technology, Inc.

  2026-06-23

• Attachment Template - The Invisalign™ Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan.

  Align Technology, Inc.

  2023-07-24

• Invisalign ART - Invisalign system treatment plan with Max. 26 stage for the treatment of malocclusion.

  Align Technology, Inc.

  2026-02-25

• Invisalign Specifix Attachment System - The Invisalign Specifix Attachment System is a patient specific system for the bonding of 3D-printed attachments onto the patient’s teeth.

  Align Technology, Inc.

  2026-02-09

• lnvisalign Specifix Attachment System (include Engagement Features) - The Invisalign Specifix Attachment System is a patient specific system for the bonding of 3D-printed attachments and engagement features onto the patient’s teeth.

  Align Technology, Inc.

  2026-02-09

• Gumlines - iTero Gumlines

  Align Technology, Inc.

  2026-01-01

• iTero Lumina – PC cfg, Interface Box - iTero Lumina IFBox FRU, PC Configuration

  Align Technology, Inc.

  2025-09-16

• iTero Lumina Software - SW, iTero Lumina Products

  Align Technology, Inc.

  2025-09-16

• iTero Lumina – PC cfg - iTero Lumina Performance PC Configuration scanning unit

  Align Technology, Inc.

  2025-09-16

• iTero Lumina – PC cfg - iTero Lumina Performance PC Configuration

  Align Technology, Inc.

  2025-09-16

• iTero Lumina – PC cfg - Paired Unit, Performance PC Config, Lumina

  Align Technology, Inc.

  2025-09-16

• iTero Lumina – PC cfg - Scanning unit Service RMA,Performance PC conf, Lumina

  Align Technology, Inc.

  2025-09-16

• iTero Lumina – PC cfg - RMA Scanning Unit, Performance PC configuration Lumina

  Align Technology, Inc.

  2025-09-16

• Invisalign Go Express - Aligner

  Align Technology, Inc.

  2025-09-15

• Invisalign™ Ultrasonic Cleaning Station - """The Invisalign Ultrasonic Cleaning Station is an over-the-counter electronic appliance that is intended to clean Invisalign® System clear aligner orthodontic appliances and Invisalign® and Vivera™ retainers using ultrasonic vibrations.The Invisalign™ Ultrasonic Cleaning Station is a countertop device that cleans Invisalign® clear aligners and Invisalign® and Vivera™ retainers by transmitting high-frequency sound waves (also called ‘ultrasonic’ vibrations) through a liquid medium, creating microscopic “scrubbing/ scouring” bubbles which dislodge debris as they collapse. The device offers a convenient way to clean these removable orthodontic appliances at home in as little as five minutes using just plain tap water and with no additional chemicals. In testing with water, the Invisalign Ultrasonic Cleaning Station removed 98.3% to 99.9% of the following odor-causing bacteria from Invisalign® clear aligners: Pseudomonas aeruginosa, Staphylococcus aureus, Klebsiella pneumoniae, Enterobacter cloacae and Escherichia coli. Performance of bacteria removal for retainers has not been evaluated."""

  Align Technology, Inc.

  2023-07-25

• Cleaning Crystals, Packette - Invisalign Cleaning Crystals

  Align Technology, Inc.

  2022-12-06

• ClinCheck - 3D Treatment Planning Software - ClinCheck Pro 6

  Align Technology, Inc.

  2022-02-17

• NuMe - Sequential Aligner

  Align Technology, Inc.

  2017-06-02

• Invisalign Full - Sequential Aligners

  Align Technology, Inc.

  2016-09-24

• Invisalign - Invisalign Retainer

  Align Technology, Inc.

  2016-09-24

• Invisalign Teen - Aligner

  Align Technology, Inc.

  2016-09-24

• Vivera - Vivera Retainer

  Align Technology, Inc.

  2016-09-24

• Invisalign System - Comprehensive - Sequential Aligners

  Align Technology, Inc.

  2017-04-24

• Invisalign System - Moderate - Sequential Aligners

  Align Technology, Inc.

  2017-04-24

• Invisalign System - Lite - Sequential Aligners

  Align Technology, Inc.

  2017-04-24

• Invisalign System - Express - Sequential Aligners

  Align Technology, Inc.

  2017-04-24

• NuMe - Sequential Aligners

  Align Technology, Inc.

  2017-04-24

• The Signature Smile - Sequential Aligner

  Align Technology, Inc.

  2017-11-10

• Invislign First - Moderate - Sequential Aligner

  Align Technology, Inc.

  2018-04-30

• Invisalign Palatal Holder - Palatal Holder

  Align Technology, Inc.

  2024-01-03

• Invisalign Palatal Expander - Palatal Expanders

  Align Technology, Inc.

  2024-01-03

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

  Align Technology, Inc.

  2025-04-15

• Vivera™ 4D Retainers - 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.

  2023-07-24

• iTero Lumina Pro - iTero Lumina Pro Software

  Align Technology, Inc.

  2025-03-06

• Invisalign Pre-Formed Attachment System - The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attachments onto the patient’s teeth. The pre-formed attachment system contains two sets of attachment positioners for each quadrant that requires attachments.

  Align Technology, Inc.

  2025-02-28

• iTero Lumina Pro - iTero Lumina Pro US Cart Configuration

  Align Technology, Inc.

  2024-11-19

• iTero Lumina Pro Mobile - iTero Lumina Pro US Mobile Configuration

  Align Technology, Inc.

  2024-11-19

• iTero Lumina Pro intraoral scanning unit - iTero Lumina Pro Scanning Unit, RMA Package US

  Align Technology, Inc.

  2024-11-19

• iTero Lumina Pro DOA - iTero Lumina Pro US DOA Kit cart

  Align Technology, Inc.

  2024-11-19

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