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FDA 510(k)

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

K-Number: K232233 · 2023-09-26

ApplicantAlign Technology, Inc.
Decision Date2023-09-26
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2023-09-26 under approval number K232233. 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 Featuring Occlusal Blocks?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is a medical device that received FDA 510(k) clearance on 2023-09-26. It is manufactured by Align Technology, Inc.. The 510(k) number is K232233.

When was Invisalign System with Mandibular Advancement Featuring Occlusal Blocks approved by the FDA?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks received FDA 510(k) clearance on 2023-09-26, under approval number K232233.

What company makes Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is manufactured by Align Technology, Inc..

What is the FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA product code for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks is NXC.

Related Clinical Trials

NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT03849534 Treatment of Temporomandibular Disorders in Children and Adolsecents WITHDRAWN NCT07103941 IOA Preventing Occlusal Changes With MAD Use RECRUITING NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class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 NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING

Other Devices by Align Technology, Inc.

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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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