ATOZ Key

GUDID 08800197900693

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)

MK Meditech Inc.

Orthodontic palate expander screw key

• Primary Device ID: 08800197900693
• NIH Device Record Key: 5c8588d7-67e4-48a4-90b2-d98194224dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOZ Key
• Version Model Number: MK Key-S
• Company DUNS: 695009476
• Company Name: MK Meditech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800197900693 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-31
• Device Publish Date: 2024-12-23

Devices Manufactured by MK Meditech Inc.

• 08800197900396 - ATOZ Utility Wire: 2025-01-06 PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and mol
• 08800197900389 - Guide ATOZ: 2025-01-03 DESCRIPTION When installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensur
• 08800197900549 - Model ATOZ: 2025-01-03 DESCRIPTION The plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide t
• 08800197900556 - ATOZ Screwdriver: 2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK
• 08800197900563 - ATOZ Screwdriver: 2024-12-31 PRODUCT SUMMARY This is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MK
• 08800197900693 - ATOZ Key: 2024-12-31DESCRIPTION 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)
• 08800197900693 - ATOZ Key: 2024-12-31 DESCRIPTION This is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside t
• 08800197900631 - ATOZ Mini-Screw: 2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the
• 08800197900648 - ATOZ Mini-Screw: 2024-12-26 The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the