Invisalign Palatal Expander

Basic Information

• Brand Name: Invisalign Palatal Expander
• Primary DI: 00816063021391
• Version / Model: 9031
• Company Name: Align Technology, Inc.
• Labeler DUNS: 013831768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-03
• Public Version: 1
• Public Version Date: 2024-01-11
• Public Version Status: New
• Public Device Record Key: f94ff2cd-2e9c-4095-8a65-a7a8f2f6ce13

Device Description

Palatal Expanders

Device Characteristics

• Single Use: No
• 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: 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
PNN	Orthodontic Software	Dental	872.5470	2
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65679	Orthodontic palate expander/teeth aligner, self-removable	An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816063021391	GS1

Premarket Submissions

Submission Number	Supplement Number
K232887	000