gudid Primary ID: 9031

Invisalign Palatal Expander (UDI 9031)

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Invisalign Palatal Expander (Model/Catalog Number: 9031) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NXC within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 9031
Product Code / EMDN: NXC
Device Name: Palatal Expanders
Database Sync Date: 2026-08-09 09:40:14

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Invisalign Palatal Expander?

The registered manufacturer of record for Invisalign Palatal Expander is Align Technology, Inc..

What is the Primary UDI-DI identifier for Invisalign Palatal Expander?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 9031.

What classification code is assigned to this device?

This device is registered under product classification code NXC.

Similar Classification Devices (NXC)

Other Devices by Align Technology, Inc.

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