Orasystems
Country not established
- Devices
- 3
What Orasystems makes
Orasystems manufactures dental hand instruments, including TKD scalers for periodontal cleaning and TDK handpieces for rotary dental procedures. The company also produces Oralube, a lubricant used in dental treatments to reduce friction and improve efficiency during procedures.
The portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the company operates from the United States.
Catalogue
Tkd Scalers Ref K000846
Regimes: 510(k) Registry: 510(k)Tdk Handpieces Ref K000848
Regimes: 510(k) Registry: 510(k)Oralube Ref K000847
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orasystems have in the registry?
The registry currently lists 3 devices for Orasystems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orasystems's devices?
Among its 3 most recently registered devices, Orasystems has devices listed in FDA 510(k) (3 devices).
What risk classes do Orasystems's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Orasystems's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orasystems in the registry?
The most recently registered devices listed for Orasystems include TKD SCALERS, TDK HANDPIECES and ORALUBE.