Luce Castle Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Luce Castle Co., Ltd. makes
Luce Castle Co., Ltd. manufactures the Luce Ceramic Bracket, a dental orthodontic appliance designed for tooth alignment. The bracket is intended for use in fixed orthodontic treatments, providing a ceramic alternative for patients seeking less visible braces.
The Luce Ceramic Bracket is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Luce Ceramic Bracket Ref K201038
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Luce Castle Co., Ltd. have in the registry?
The registry currently lists 1 device for Luce Castle Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Luce Castle Co., Ltd.'s devices?
Among its 1 most recently registered device, Luce Castle Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Luce Castle Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Luce Castle Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Luce Castle Co., Ltd. in the registry?
The most recently registered devices listed for Luce Castle Co., Ltd. include Luce Ceramic Bracket.