ClearCorrect System REF-02

GUDID D865REF0002

Engager template device accessory for use with the ClearCorrect System.

Clearcorrect Operating, LLC

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• Primary Device ID: D865REF0002
• NIH Device Record Key: 704a57ef-6b14-48f6-be77-097ac33632ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearCorrect System
• Version Model Number: MFG-0101 1.0
• Catalog Number: REF-02
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com
• Phone: (888) 331-3323
• Email: support@clearcorrect.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D865REF0002 [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: 2019-04-16
• Device Publish Date: 2019-04-08

Devices Manufactured by Clearcorrect Operating, LLC

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• D865REF03001 - ClearCorrect System: 2023-09-04 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to
• D865REF04001 - ClearCorrect System: 2023-09-04 The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth i
• D865REF05001 - ClearCorrect System: 2023-09-04 The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively re
• D865REF00011 - ClearCorrect System: 2020-07-31 The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively r
• D865REF00021 - ClearCorrect System: 2020-07-31 Engager template device accessory for use with the ClearCorrect System.
• D865REF00031 - ClearCorrect System: 2020-07-31 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to