K231913
- 510(k) number
- K231913
- Device name
- T-FIT
- Applicant
- Techwin Co., Ltd. KR
- Product code
- OAT — Implant, Endosseous, Orthodontic
- Decision date
- 2024-02-08
- Date received
- 2023-06-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K231913.pdf
Official FDA record: K231913
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.