gudid Primary ID: 211385

iTero Computing Unit (UDI 211385)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The iTero Computing Unit (Model/Catalog Number: 211385) 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: 211385
Product Code / EMDN: NOF
Device Name: Scanner computer 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 Computing Unit?

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

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 211385.

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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