Cleared Traditional

Mico One Orthodontic Screw

K202163 · Ze Fang Technology Co., Ltd. · Dental

Oct 2022

Decision

795d

Days

Class 2

Risk

About This 510(k) Submission

K202163 is an FDA 510(k) clearance for the Mico One Orthodontic Screw, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Ze Fang Technology Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on October 7, 2022, 795 days after receiving the submission on August 3, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K202163 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2020
Decision Date	October 07, 2022
Days to Decision	795 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.