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FDA 510(k)

Invisalign System with Mandibular Advancement Feature

K-Number: K181739 · 2018-10-26

ApplicantAlign Technology, Inc.
Decision Date2018-10-26
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign System with Mandibular Advancement Feature is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2018-10-26 under approval number K181739. 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 with Mandibular Advancement Feature?

Invisalign System with Mandibular Advancement Feature is a medical device that received FDA 510(k) clearance on 2018-10-26. It is manufactured by Align Technology, Inc.. The 510(k) number is K181739.

When was Invisalign System with Mandibular Advancement Feature approved by the FDA?

Invisalign System with Mandibular Advancement Feature received FDA 510(k) clearance on 2018-10-26, under approval number K181739.

What company makes Invisalign System with Mandibular Advancement Feature?

Invisalign System with Mandibular Advancement Feature is manufactured by Align Technology, Inc..

What is the FDA product code for Invisalign System with Mandibular Advancement Feature?

The FDA product code for Invisalign System with Mandibular Advancement Feature is NXC.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT02071134 Registry of Deep Brain Stimulation With the VERCISE™ System: Vercise DBS Registry RECRUITING NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION

Other Devices by Align Technology, Inc.

K193659iTero Element 5D K222894Invisalign System, Pre-Formed Attachment System K220287Invisalign System K232887Invisalign Palatal Expander System K232233Invisalign System with Mandibular Advancement Featuring Occlusal Blocks K241412Invisalign System

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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.

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