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FDA 510(k)

Invisalign® Palatal Expander System

K-Number: K252931 · 2025-10-23

ApplicantAlign Technology, Inc.
Decision Date2025-10-23
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Invisalign® Palatal Expander System 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 2025-10-23 under 510(k) number K252931. 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® Palatal Expander System?

Invisalign® Palatal Expander System is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Align Technology, Inc.. The 510(k) number is K252931.

When did Invisalign® Palatal Expander System receive FDA 510(k) clearance?

Invisalign® Palatal Expander System received FDA 510(k) clearance on 2025-10-23, under 510(k) number K252931.

Who is the listed applicant for Invisalign® Palatal Expander System?

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® Palatal Expander System?

The FDA product code for Invisalign® Palatal Expander System is NXC.

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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™ ProK252870Invisalign Specifix Attachment SystemK252380Invisalign SystemK240573iTero Lumina™ ProK241412Invisalign SystemK232887Invisalign Palatal Expander 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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