gudid Primary ID: 223114

iTero Lumina PC cfg (UDI 223114)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina PC cfg (Model/Catalog Number: 223114) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NOF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 223114
Product Code / EMDN: NOF
Device Name: RMA Scanning Unit, Performance PC configuration Lumina
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 PC cfg?

The registered manufacturer of record for iTero Lumina PC cfg is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Lumina PC cfg?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 223114.

What classification code is assigned to this device?

This device is registered under product classification code NOF.

Similar Classification Devices (NOF)

Other Devices by Align Technology, Inc.

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