Name: Predicase
Price: 199 USD

K-number	K252931
Device name	Invisalign® Palatal Expander System
Applicant	Align Technology, Inc.
Product code	NXC
Device class	Class II
Decision date	Oct 23, 2025
Decision	Substantially Equivalent
Regulation	872.5470

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Invisalign® Palatal Expander System

Everything you need for a 510(k) submission. Nothing you don't.