gudid Primary ID: 100012

Attachment Template (UDI 100012)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Attachment Template (Model/Catalog Number: 100012) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification QJJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 100012
Product Code / EMDN: QJJ
Device Name: The Invisalign Attachment Templates are disposable polyurethane accessory to Invisalign System and are intended to guide the placement of dental composite (material provided by doctor) to the tooth surface to create shapes known as attachments, which are used for aligner retention or optimized aligner force system for tooth movement. The configuration and types of attachments shapes are defined by the treatment plan.
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 Attachment Template?

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

What is the Primary UDI-DI identifier for Attachment Template?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 100012.

What classification code is assigned to this device?

This device is registered under product classification code QJJ.

Similar Classification Devices (QJJ)

Other Devices by Align Technology, Inc.

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