gudid Primary ID: 5035

Invisalign Specifix Attachment System (UDI 5035)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Invisalign Specifix Attachment System (Model/Catalog Number: 5035) is a medical device manufactured by Align Technology, Inc.. This product is indexed under FDA Product Code / Category Classification NXC within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 5035
Product Code / EMDN: NXC
Device Name: The Invisalign Specifix Attachment System is a patient specific system for the bonding of 3D-printed attachments onto the patients teeth.
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 Invisalign Specifix Attachment System?

The registered manufacturer of record for Invisalign Specifix Attachment System is Align Technology, Inc..

What is the Primary UDI-DI identifier for Invisalign Specifix Attachment System?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5035.

What classification code is assigned to this device?

This device is registered under product classification code NXC.

Similar Classification Devices (NXC)

Other Devices by Align Technology, Inc.

Programmatic Export

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

JSON API Endpoint