ClearCorrect System

Basic Information

• Brand Name: ClearCorrect System
• Primary DI: D865REF00021
• Version / Model: Engager Template
• Catalog Number: REF-02
• Company Name: Clearcorrect Operating, LLC
• Labeler DUNS: 016449078
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-23
• Public Version: 4
• Public Version Date: 2023-08-28
• Public Version Status: Update
• Public Device Record Key: 989477bd-dba2-401a-b75b-6ccfaaa5a485
• Distribution End Date: 2023-08-25

Device Description

Engager template device accessory for use with the ClearCorrect System.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65436	Orthodontic resin positioning tray	A custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light-cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing. It is typically made of synthetic polymer materials and is manufactured from an orthodontic treatment plan based on an oral cavity impression or oral scan for a specific patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D865REF00021	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]