gudid Primary ID: 211782

iTero Element Scanning Unit (UDI 211782)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Element Scanning Unit (Model/Catalog Number: 211782) 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: 211782
Product Code / EMDN: NOF
Device Name: Scanning unit
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 Element Scanning Unit?

The registered manufacturer of record for iTero Element Scanning Unit is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Element Scanning Unit?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 211782.

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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