GUDIDData
gudid Primary ID: Retainer

ClearCorrect System (UDI Retainer)

Manufactured by Clearcorrect Operating, LLC

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ClearCorrect System - Primary ID Retainer

Device Regulatory Overview

The ClearCorrect System (Model/Catalog Number: Retainer) is a medical device manufactured by Clearcorrect Operating, LLC. This product is indexed under FDA Product Code / Category Classification KMY within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Retainer
Product Code / EMDN
KMY
Device Name
The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application.
Database Sync Date
2026-08-09 09:03:36

Full Regulatory Attributes

🔒 Token Gated
{
    "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 ClearCorrect System?

The registered manufacturer of record for ClearCorrect System is Clearcorrect Operating, LLC.

What is the Primary UDI-DI identifier for ClearCorrect System?

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

What classification code is assigned to this device?

This device is registered under product classification code KMY.

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