T-FIT— 510(k) K231913

Name: FDA 510(k) clearance K231913
Creator: U.S. Food and Drug Administration
Published: 2024-02-08

Substantially Equivalent

Techwin Co., Ltd.

FDA 510(k) clearance K231913 for T-FIT, Substantially Equivalent on 2024-02-08. Applicant: Techwin Co., Ltd.. Device class: 2.

Clearance details

Applicant: Techwin Co., Ltd.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2023-06-29
Decision date: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, KR

Download summary PDF View on FDA.gov ↗

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K231932 — TDS (TECHWIN DENTAL SYSTEM)2024-08-20

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.