Orthosun Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Orthosun Co., Ltd. makes
Orthosun Co., Ltd. manufactures the Mei Ceramic Bracket, a dental orthodontic attachment designed for tooth alignment treatment.
The Mei Ceramic Bracket is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Mei Ceramic Bracket Ref K190608
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orthosun Co., Ltd. have in the registry?
The registry currently lists 1 device for Orthosun Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthosun Co., Ltd.'s devices?
Among its 1 most recently registered device, Orthosun Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Orthosun Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Orthosun Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orthosun Co., Ltd. in the registry?
The most recently registered devices listed for Orthosun Co., Ltd. include Mei Ceramic Bracket.