Cleared Traditional

T-FIT

K231913 · Techwin Co., Ltd. · Dental

Feb 2024

Decision

224d

Days

Class 2

Risk

About This 510(k) Submission

K231913 is an FDA 510(k) clearance for the T-FIT, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Techwin Co., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on February 8, 2024, 224 days after receiving the submission on June 29, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K231913 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2023
Decision Date	February 08, 2024
Days to Decision	224 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.