gudid Primary ID: 214500

iTero Lumina scanning unit (UDI 214500)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Lumina scanning unit (Model/Catalog Number: 214500) 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: 214500
Product Code / EMDN: NOF
Device Name: Scanning unit (wand)
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 scanning unit?

The registered manufacturer of record for iTero Lumina scanning unit is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Lumina scanning unit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 214500.

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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