Invisalign UV Sanitizing Case

Basic Information

• Brand Name: Invisalign UV Sanitizing Case
• Primary DI: 00816063021896
• Version / Model: 214150
• Company Name: Align Technology, Inc.
• Labeler DUNS: 013831768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: d6c2b032-19fc-4a49-9233-9edfcd33fa74

Device Description

The Invisalign UV Sanitizing Case is a portable, over-the-counter device that is intended to sanitize Invisalign clear aligners.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile	Dental	872.6855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44734	Orthodontic appliance automated cleaner	An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816063021896	GS1