Cleared Traditional

ATOZ Mini-Screw

K210559 · Mk Meditech, Inc. · Dental

Dec 2021

Decision

297d

Days

Class 2

Risk

About This 510(k) Submission

K210559 is an FDA 510(k) clearance for the ATOZ Mini-Screw, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Mk Meditech, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on December 19, 2021, 297 days after receiving the submission on February 25, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K210559 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2021
Decision Date	December 19, 2021
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	OAT — Implant, Endosseous, Orthodontic
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3640
Definition	It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.