Cleared Traditional

Ortho MI System

K211992 · Osteonic Co., Ltd. · Dental

Oct 2021

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K211992 is an FDA 510(k) clearance for the Ortho MI System, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Osteonic Co., Ltd. (Guro-Gu, KR). The FDA issued a Cleared decision on October 15, 2021, 109 days after receiving the submission on June 28, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K211992 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 2021
Decision Date	October 15, 2021
Days to Decision	109 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.