World Bio Tech Co., Ltd.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What World Bio Tech Co., Ltd. makes
World Bio Tech Co., Ltd. manufactures orthodontic brackets, including metal MACH BRACKETS and ceramic BIJOU Orthodontic Brackets, designed for dental alignment applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Mach Brackets Bright Brackets Ref K120471
Regimes: 510(k) Registry: 510(k)BIJOU Orthodontic Ceramic Bracket Ref K152167
Regimes: 510(k) Registry: 510(k)
FDA establishments
- World Bio Tech Co Ltd Seongnam-si Gyeonggi · KR FEI 3009438612
Frequently asked questions
How many devices does World Bio Tech Co., Ltd. have in the registry?
The registry currently lists 2 devices for World Bio Tech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list World Bio Tech Co., Ltd.'s devices?
Among its 2 most recently registered devices, World Bio Tech Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do World Bio Tech Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for World Bio Tech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from World Bio Tech Co., Ltd. in the registry?
The most recently registered devices listed for World Bio Tech Co., Ltd. include MACH BRACKETS BRIGHT BRACKETS and BIJOU Orthodontic Ceramic Bracket.
Which FDA establishments are linked to World Bio Tech Co., Ltd.?
1 FDA establishment is linked to World Bio Tech Co., Ltd. in the registry; they are listed on the company page.