Techwin Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 2
What Techwin Co., Ltd. makes
Techwin Co., Ltd. manufactures dental imaging systems, including the TECHWIN DENTAL SYSTEM (TDS) for intraoral and extraoral radiographic imaging, and the T-FIT, a digital imaging solution designed for precise dental diagnostics.
The company’s portfolio is regulated under FDA Class II devices, with products listed via the 510(k) pathway. Techwin Co., Ltd. is based in the United States.
Catalogue
Tds (Techwin Dental System) Ref K231932
Regimes: 510(k) Registry: 510(k)T-Fit Ref K231913
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Techwin Co., Ltd. have in the registry?
The registry currently lists 2 devices for Techwin Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Techwin Co., Ltd.'s devices?
Among its 2 most recently registered devices, Techwin Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Techwin Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Techwin Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Techwin Co., Ltd. in the registry?
The most recently registered devices listed for Techwin Co., Ltd. include TDS (TECHWIN DENTAL SYSTEM) and T-FIT.