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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 the device name listed in this FDA 510(k) record. The listed applicant is Align Technology, Inc.. It received FDA 510(k) clearance on 2023-09-26 under 510(k) 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. The listed applicant is Align Technology, Inc.. The 510(k) number is K232233.

When did Invisalign System with Mandibular Advancement Featuring Occlusal Blocks receive FDA 510(k) clearance?

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

Who is the listed applicant for Invisalign System with Mandibular Advancement Featuring Occlusal Blocks?

The FDA 510(k) record lists Align Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06576310Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement ApplianceRECRUITINGNCT06970171Acceptance of Mandibular Advancement DevicesENROLLING_BY_INVITATIONNCT07103941IOA Preventing Occlusal Changes With MAD UseRECRUITINGNCT07703007Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III MalocclusionENROLLING_BY_INVITATION

Other records listing Align Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261847iTero Lumina™ ProK252931Invisalign® Palatal Expander SystemK252870Invisalign Specifix Attachment SystemK252380Invisalign SystemK240573iTero Lumina™ ProK241412Invisalign System

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Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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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