American Ormco
Country not established
- Devices
- 2
What American Ormco makes
American Ormco manufactures orthodontic appliances, including lingual brackets for tooth alignment and Crystal-Bond adhesive systems used to secure brackets to teeth.
Their products are regulated under FDA Class I and Class II classifications, with relevant devices listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Lingual Bracket Ref K812300
Regimes: 510(k) Registry: 510(k)Crystal-Bond Ref K810241
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Ormco have in the registry?
The registry currently lists 2 devices for American Ormco. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Ormco's devices?
Among its 2 most recently registered devices, American Ormco has devices listed in FDA 510(k) (2 devices).
What risk classes do American Ormco's devices fall under?
Among its 2 most recently registered devices, the classes recorded for American Ormco's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Ormco in the registry?
The most recently registered devices listed for American Ormco include LINGUAL BRACKET and CRYSTAL-BOND.