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T-FIT

by Techwin Co., Ltd.

510(k) K231913

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231913 Date8 Feb 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OAT
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The T-FIT is an endosseous orthodontic implant classified as a Class 2 dental device under product code OAT. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13) and has been determined to be substantially equivalent to predicate devices in terms of indications for use, function, and performance related to technological characteristics.

The T-FIT received FDA 510(k) clearance (K231913) via the traditional pathway on February 8, 2024, following a 224-day review. It is manufactured by Techwin Co., Ltd. and is intended for use in dental applications as an orthodontic implant.

Other devices from Techwin Co., Ltd.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the T-FIT used for?

    The T-FIT is an endosseous orthodontic implant intended for use in dental applications as an orthodontic implant, as stated in its FDA 510(k) clearance documentation.

  • What material is the T-FIT made from?

    The T-FIT is made of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13), as specified in its device description for biocompatibility and performance in orthodontic applications.

  • When did the T-FIT receive FDA clearance?

    The T-FIT received FDA 510(k) clearance (K231913) via the traditional pathway on February 8, 2024, following a 224-day review period starting from June 29, 2023.

  • Who manufactures the T-FIT?

    The T-FIT is manufactured by Techwin Co., Ltd., located at #401, Eungyenam-Gil 40, Siheung-Si, KR 14922, as listed in the device’s authorization and establishment registration details.