ATOZ Expander

GUDID 08800197900037

The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch. For the procedure, the ATOZ Expander is placed under the patient's palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient's palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient's palate is sufficiently wide. INDICATION FOR USE The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch Trade Name: ATOZ Expander Model Number: MKE-08-F

MK Meditech Inc.

Orthodontic palate expander/teeth aligner, bonded

• Primary Device ID: 08800197900037
• NIH Device Record Key: b7c31119-9555-43c0-aa73-1f25ac527a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOZ Expander
• Version Model Number: MKE-08-F
• Company DUNS: 695009476
• Company Name: MK Meditech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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	08800197900037 [Primary]

FDA Product Code

• DYJ: Retainer, Screw Expansion, Orthodontic

Sterilization

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

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

[08800197900037]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-31
• Device Publish Date: 2022-01-22

On-Brand Devices [ATOZ Expander]

• 08800197900037: The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase
• 08800197900358: The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase
• 08800197900372: The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase