ATOZ Key

Basic Information

• Brand Name: ATOZ Key
• Primary DI: 08800197900693
• Version / Model: MK Key-S
• Company Name: MK Meditech Inc.
• Labeler DUNS: 695009476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-23
• Public Version: 1
• Public Version Date: 2024-12-31
• Public Version Status: New
• Public Device Record Key: 5c8588d7-67e4-48a4-90b2-d98194224dac

Device Description

DESCRIPTION This is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USE This is a product to expand the ATOZ expander. TRADE NAME ATOZ Key MODEL NUMBER Shorter key (MK Key-S)

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64768	Orthodontic palate expander screw key	A hand-held device designed to manually adjust an orthodontic palate expander (not included), by rotating the expander’s screw, to help create space for correct upper teeth alignment. It is comprised of a handle with an expander-engaging pin at the distal end which is inserted into the screw and rotated to adjust the width of the expander. This is a reusable device intended for single patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800197900693	GS1