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 a medical device manufactured by Align Technology, Inc.. It received FDA 510(k) clearance on 2025-10-23 under approval 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. It is manufactured by Align Technology, Inc.. The 510(k) number is K252931.
When was Invisalign® Palatal Expander System approved by the FDA?
Invisalign® Palatal Expander System received FDA 510(k) clearance on 2025-10-23, under approval number K252931.
What company makes Invisalign® Palatal Expander System?
Invisalign® Palatal Expander System is manufactured by Align Technology, Inc..
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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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.