Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Invisalign System, Pre-Formed Attachment System

K-Number: K222894 · 2022-12-22

ApplicantAlign Technology, Inc.
Decision Date2022-12-22
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign System, Pre-Formed Attachment System is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2022-12-22 under approval number K222894. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invisalign System, Pre-Formed Attachment System?

Invisalign System, Pre-Formed Attachment System is a medical device that received FDA 510(k) clearance on 2022-12-22. It is manufactured by Align Technology, Inc.. The 510(k) number is K222894.

When was Invisalign System, Pre-Formed Attachment System approved by the FDA?

Invisalign System, Pre-Formed Attachment System received FDA 510(k) clearance on 2022-12-22, under approval number K222894.

What company makes Invisalign System, Pre-Formed Attachment System?

Invisalign System, Pre-Formed Attachment System is manufactured by Align Technology, Inc..

What is the FDA product code for Invisalign System, Pre-Formed Attachment System?

The FDA product code for Invisalign System, Pre-Formed Attachment System is NXC.

Related Clinical Trials

NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05905224 Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol COMPLETED

Other Devices by Align Technology, Inc.

K181739Invisalign System with Mandibular Advancement Feature K193659iTero Element 5D K220287Invisalign System K232887Invisalign Palatal Expander System K232233Invisalign System with Mandibular Advancement Featuring Occlusal Blocks K241412Invisalign System

View all 10 devices →

Related Devices (Code: NXC)

K151965Dentti SystemMartz, Inc. K162609ClearPath AlignerClearpath Orthodontics, Ltd. K163155MTM Clear AlignerDentsply Sirona K1636893M Clear Tray Aligner3M Unitek Corporation K1831593M Clarity Aligners3M Company K182329SureCure Orthodontic Aligner SystemDigital Orthodontic Care

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑