GUDIDData
gudid Primary ID: 211572

iTero Element 5D Plus upgrade cart configuration (UDI 211572)

Manufactured by Align Technology, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iTero Element 5D Plus upgrade cart configuration - Primary ID 211572

Device Regulatory Overview

The iTero Element 5D Plus upgrade cart configuration (Model/Catalog Number: 211572) 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
211572
Product Code / EMDN
NTK
Device Name
Scanner, upgrade cart configuration
Database Sync Date
2026-08-09 09:40:14

Full Regulatory Attributes

🔒 Token Gated
{
    "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 upgrade cart configuration?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 211572.

What classification code is assigned to this device?

This device is registered under product classification code NTK.

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