ATOZ Mini-Screw

FDA UDI

Class II (US FDA UDI)

by M.K. Meditech Co. , Ltd.

Identity

Trade Name: ATOZ Mini-Screw FDA UDI
Generic Name: Orthodontic anchoring screw FDA UDI
Device Name: 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 FDA UDI
Model / Reference: MKS-1611 FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800197900198 FDA UDI
510(k) Number: K210559 FDA UDI
FDA Product Code: OAT FDA UDI
GMDN Term: Orthodontic anchoring screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Orthodontic anchoring screw

ATOZ Mini-Screw by M.K. Meditech Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic anchoring screw.

Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Absoanchor Microimplant — DENTOS Inc. · Class II
Absoanchor Microimplant — DENTOS Inc. · Class II
GBR System Bone Screw — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: M.K. Meditech Co. , Ltd.

Sources (1)

FDA UDI dbf04435-fd6e-440f-b345-909f5e041388 34 fields · synced May 30, 2026