ATOZ Mini-Screw

GUDID 08800197900297

The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied

MK Meditech Inc.

Orthodontic anchoring screw

• Primary Device ID: 08800197900297
• NIH Device Record Key: e878fb77-de28-470b-86f9-09631a8c877a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATOZ Mini-Screw
• Version Model Number: MKS-1613
• Company DUNS: 695009476
• Company Name: MK Meditech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	08800197900297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210559

FDA Product Code

• OAT: Implant, Endosseous, Orthodontic

Sterilization

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

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

[08800197900297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-26
• Device Publish Date: 2023-07-18

On-Brand Devices [ATOZ Mini-Screw]

• 08800197900020: DESCRIPTION The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatm
• 08800197900136: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900129: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900112: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900105: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900099: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900310: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900297: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900303: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900334: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900198: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900686: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900679: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900662: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900655: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900648: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave
• 08800197900631: The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment. The ave