Clear Image Aligner: Lower (Z-FLX)

Basic Information

• Brand Name: Clear Image Aligner: Lower (Z-FLX)
• Primary DI: D8197001040
• Version / Model: 700104
• Company Name: SPECIALTY APPLIANCES, LLC
• Labeler DUNS: 106645484
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-16
• Public Version: 1
• Public Version Date: 2023-10-24
• Public Version Status: New
• Public Device Record Key: 916b6f81-832c-4ffc-8cc6-7211a64d17b0

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
44738	Orthodontic progressive aligner	A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8197001040	HIBCC