Ortho Caps GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Ortho Caps GmbH makes
Ortho Caps GmbH manufactures the Orthocaps Twinaligner, a device designed for dental alignment and orthodontic treatment. This product is intended for use in correcting tooth positioning and improving bite alignment through clear aligner technology.
The company’s portfolio is regulated under Class II devices in the United States, with the Orthocaps Twinaligner authorised through the FDA’s 510(k) clearance process. The manufacturer operates from the US.
Catalogue
Orthocaps Twinaligner Ref K180241
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ortho Caps GmbH have in the registry?
The registry currently lists 1 device for Ortho Caps GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortho Caps GmbH's devices?
Among its 1 most recently registered device, Ortho Caps GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Ortho Caps GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Ortho Caps GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortho Caps GmbH in the registry?
The most recently registered devices listed for Ortho Caps GmbH include Orthocaps Twinaligner.