gudid Primary ID: 211378

iTero Element 5D Plus US wand upgrade (UDI 211378)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Element 5D Plus US wand upgrade (Model/Catalog Number: 211378) 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: 211378
Product Code / EMDN: NTK
Device Name: Scanner, wand upgrade
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 5D Plus US wand upgrade?

The registered manufacturer of record for iTero Element 5D Plus US wand upgrade is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Element 5D Plus US wand upgrade?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 211378.

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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