Kline Europe GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Kline Europe GmbH makes
Kline Europe GmbH manufactures the K Clear, a dental device designed for intraoral cleaning and polishing, primarily used in professional dental settings to remove plaque and stains from teeth surfaces.
The K Clear 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
K Clear Ref K220726
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kline Europe GmbH have in the registry?
The registry currently lists 1 device for Kline Europe GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kline Europe GmbH's devices?
Among its 1 most recently registered device, Kline Europe GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Kline Europe GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Kline Europe GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kline Europe GmbH in the registry?
The most recently registered devices listed for Kline Europe GmbH include K Clear.