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Invisalign, product family

by Align Technology Inc. 20 variants Basic UDI-DI 081606302INVISALIGNMH

Shared by every variant

Manufacturer
Align Technology Inc.(20)
Basic UDI-DI
081606302INVISALIGNMH
Risk class
Class IIa
Legislation
MDR
EMDN category
ORTHODONTIC DEVICES - OTHER
Market status
20 on the market
Official record
EUDAMED public site — Open the EUDAMED public site, choose Devices, and search for the Basic UDI-DI 081606302INVISALIGNMH.

Certificates

1 certificate naming this Basic UDI-DI · EUDAMED

  • 3831212CE01 Quality management system · refdata.applicable-legislation.mdr supplemented
    Notified body 0344 · holder Align Technology Inc. · issued 2 Jul 2026 · expires 28 Oct 2029

Recalls

1 recall · FDA

  • Z-1017-2023 Class II · completed · 5 Dec 2022
    3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.

Recalls matched to the 20 devices listed on this page; other pages of the family can carry others.

Variants

20 devices · page 1 of 1

Variants of Invisalign, Basic UDI-DI 081606302INVISALIGNMH
UDI-DISize and differences
Invisalign ART 9050 / Invisalign System00816063023180 —On the market
Invisalign Comprehensive Intervals 9052 / Invisalign System00816063023883 —On the market
Invisalign First Intervals 9051 / Invisalign System00816063023876 —On the market
Invisalign First-Comprehensive 9007 / Invisalign System00816063020264 —On the market
Invisalign First-Moderate 9006 / Invisalign System00816063020257 —On the market
Invisalign Full 8500 / Invisalign System00816063020004 —On the market
Invisalign Go 8612 / Invisalign System00816063020127 —On the market
Invisalign Go 9014 / Invisalign System00816063020424 —On the market
Invisalign Go Express 9033 / Invisalign System00816063021377 —On the market
Invisalign Go Plus 9012 / Invisalign System00816063020431 —On the market
Invisalign i7 8528 / Invisalign System00816063020073 —On the market
Invisalign Lite 8523 / Invisalign System00816063020066 —On the market
Invisalign System - Comprehensive 9000 / Invisalign System00816063020189 —On the market
Invisalign System - Moderate 9001 / Invisalign System00816063020196 —On the market
Invisalign System - Teen Package 9037 / Invisalign System00816063021636 —On the market
Invisalign System – Express 9003 / Invisalign System00816063020219 —On the market
Invisalign System – Lite 9002 / Invisalign System00816063020202 —On the market
Invisalign System-Comprehensive Phase 2 9011 / Invisalign System00816063020271 —On the market
Invisalign Teen 8506 / Invisalign System00816063020035 —On the market
Invisalign Touch-up 9023 / Invisalign System00816063020530 —On the market