gudid Primary ID: 226797

Gumlines (UDI 226797)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Gumlines (Model/Catalog Number: 226797) 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: 226797
Product Code / EMDN: NOF
Device Name: iTero Gumlines
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 Gumlines?

The registered manufacturer of record for Gumlines is Align Technology, Inc..

What is the Primary UDI-DI identifier for Gumlines?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 226797.

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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