Orthoworld LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000037185
- Devices
- 12
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- MDSS GmbHDE
What Orthoworld LLC makes
Orthoworld LLC manufactures orthodontic archwires and bracket kits under the Fastbraces® brand, including metal, clear, and hybrid systems designed for accelerated tooth alignment. Products include pre-loaded archwire kits and standalone brackets, such as the Turbo® and Classic series, tailored for clinical efficiency and patient comfort.
These devices are classified as Class IIa under EU regulations and are registered in the EUDAMED database. The company is based in the United States, where its products are subject to applicable medical device compliance requirements.
Catalogue
Search and filter all 12 devicesCompany details
- EUDAMED SRN
- US-MF-000037185
- EUDAMED status
- Active
- EUDAMED registered name
- Orthoworld LLC
- Registered address
- 2670, FM 983, 75154, Red Oak, United States
- Website
- www.fastbraces.com
- [email protected]
- Phone
- 7817795768
- PRRC contact
- Carolyn Russell
Frequently asked questions
How many devices does Orthoworld LLC have in the registry?
The registry currently lists 12 devices for Orthoworld LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthoworld LLC's devices?
Among its 12 most recently registered devices, Orthoworld LLC has devices listed in EUDAMED (12 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Orthoworld LLC's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Orthoworld LLC's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from Orthoworld LLC in the registry?
The most recently registered devices listed for Orthoworld LLC include Fastbraces® COMBO Turbo® Archwires, Fastbraces® CLASSIC Metal Bracket Kit, Fastbraces® CLASSIC Clear Bracket Kit and Fastbraces® Turbo® Xtra Archwires.