Orec Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Orec Corp. makes
Orec Corp. manufactures orthodontic elastics and metal brackets, which are used in fixed orthodontic appliances to apply controlled forces for tooth alignment and bite correction.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Orthodontic Elastics Ref K810010
Regimes: 510(k) Registry: 510(k)Orthodontic Bracket Ref K803316
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orec Corp. have in the registry?
The registry currently lists 2 devices for Orec Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orec Corp.'s devices?
Among its 2 most recently registered devices, Orec Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Orec Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Orec Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Orec Corp. in the registry?
The most recently registered devices listed for Orec Corp. include ORTHODONTIC ELASTICS and ORTHODONTIC BRACKET.