ClearCorrect System REF-05

GUDID D865REF05001

The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.

Clearcorrect Operating, LLC

Orthodontic progressive aligner

• Primary Device ID: D865REF05001
• NIH Device Record Key: a5822d35-f9ae-48ec-81a3-3809a9c62024
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCorrect System
• Version Model Number: Aligner (Single-layer)
• Catalog Number: REF-05
• Company DUNS: 016449078
• Company Name: Clearcorrect Operating, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	D865REF00051 [Previous]
HIBCC	D865REF05001 [Primary]

FDA Product Code

• NXC: Aligner, Sequential

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.