ClearCorrect System REF04

GUDID D865REF04001

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.

Clearcorrect Operating, LLC

Orthodontic retainer Orthodontic retainer

• Primary Device ID: D865REF04001
• NIH Device Record Key: e74b1e9b-c345-47fd-ae44-6187649242e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCorrect System
• Version Model Number: Retainer
• Catalog Number: REF04
• Company DUNS: 016449078
• Company Name: Clearcorrect Operating, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-331-3323
• Email: support@clearcorrect.com
• Phone: 888-331-3323
• Email: support@clearcorrect.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D865REF00041 [Previous]
HIBCC	D865REF04001 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [ClearCorrect System]

• D865REF0001: The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ
• D865REF00051: The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a seque
• D865REF00041: The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic a
• D865REF00031: The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite
• D865REF00021: Engager template device accessory for use with the ClearCorrect System.
• D865REF00011: The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequ
• D865REF05001: The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a seque
• D865REF04001: The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic a
• D865REF03001: The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite
• D865REF02001: Engager template device accessory for use with the ClearCorrect System.