gudid Primary ID: 855-204

Ceramic Button (UDI 855-204)

Manufactured by AMERICAN ORTHODONTICS CORPORATION

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Ceramic Button (Model/Catalog Number: 855-204) is a medical device manufactured by AMERICAN ORTHODONTICS CORPORATION. This product is indexed under FDA Product Code / Category Classification ECN within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 855-204
Product Code / EMDN: ECN
Device Name: DB CERAMIC BUTTON 10/PKG
Database Sync Date: 2026-08-09 09:00:41

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 Ceramic Button?

The registered manufacturer of record for Ceramic Button is AMERICAN ORTHODONTICS CORPORATION.

What is the Primary UDI-DI identifier for Ceramic Button?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 855-204.

What classification code is assigned to this device?

This device is registered under product classification code ECN.

Similar Classification Devices (ECN)

Other Devices by AMERICAN ORTHODONTICS CORPORATION

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