gudid Primary ID: 221971

iTero Lumina Pro DOA (UDI 221971)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina Pro DOA (Model/Catalog Number: 221971) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NTK within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 221971
Product Code / EMDN: NTK
Device Name: iTero Lumina Pro US DOA Kit cart
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 iTero Lumina Pro DOA?

The registered manufacturer of record for iTero Lumina Pro DOA is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Lumina Pro DOA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 221971.

What classification code is assigned to this device?

This device is registered under product classification code NTK.

Similar Classification Devices (NTK)

Other Devices by Align Technology, Inc.

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