Aligner Treatment Starter Kitz

Basic Information

• Brand Name: Aligner Treatment Starter Kitz
• Primary DI: 00850035489079
• Version / Model: 0850035489
• Catalog Number: ORN0006-03
• Company Name: Orthonu LLC
• Labeler DUNS: 125732548
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-04
• Public Version: 1
• Public Version Date: 2025-06-12
• Public Version Status: New
• Public Device Record Key: 2453aef2-5709-4e9d-9c79-dca0fd8f2f00

Device Description

A Kit with 5 products including Tweakz for Aligners, comfort tape, mouth-aid, OrthoChewz and Chillin’ Strips.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
NYC	Dental Prophylaxis Kit	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44406	Dental restoration/appliance emergency fix kit	A convenient collection of the necessary equipment and materials, typically used in an emergency by a layperson, to refix a dental restoration or appliance. It is typically used to temporarily refix dislodged crowns, bridges, fillings, or inlays to restore appearance and function without professional assistance. It typically consists of dental adhesive materials and mixing and application utensils. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850035489079	GS1

Customer Contacts

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