gudid Primary ID: 209157

iTero Element 5D LC Upgrade, Kit US (UDI 209157)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Element 5D LC Upgrade, Kit US (Model/Catalog Number: 209157) 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: 209157
Product Code / EMDN: NTK
Device Name: Scanner Upgrade Kit
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
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of iTero Element 5D LC Upgrade, Kit US?

The registered manufacturer of record for iTero Element 5D LC Upgrade, Kit US is Align Technology, Inc..

What is the Primary UDI-DI identifier for iTero Element 5D LC Upgrade, Kit US?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 209157.

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.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint