Swissmeditec GmbH
SwitzerlandFDA applicant, unverified
- Devices
- 1
What Swissmeditec GmbH makes
Swissmeditec GmbH manufactures a range of dental implants, including the Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, and Medi White Pearl. These products are designed for dental restoration, providing solutions for posterior and anterior tooth replacement with varying material compositions and surface treatments.
The company’s portfolio is regulated under Class II medical devices in the US, with devices listed via the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl Ref K170873
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Swissmeditec GmbH have in the registry?
The registry currently lists 1 device for Swissmeditec GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swissmeditec GmbH's devices?
Among its 1 most recently registered device, Swissmeditec GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Swissmeditec GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Swissmeditec GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Swissmeditec GmbH in the registry?
The most recently registered devices listed for Swissmeditec GmbH include Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl.