Osyris
FranceFDA applicant, unverified
- Devices
- 3
What Osyris makes
Osyris manufactures dental handpieces and related accessories, including rotary instruments like the SMOOTHKIT+ for endodontic and periodontal procedures, and high-speed handpieces such as the PHARAON 980 (ENDO/EXO), OSYFIBRE 600, and CONTROL4+ for precision cutting. The PHARAON LIPO is designed for liposuction applications in surgical dentistry.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Osyris is based in the United States.
Catalogue
Smoothkit+ Ref K082004
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Pharaon Lipo Ref K073617
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Osyris have in the registry?
The registry currently lists 3 devices for Osyris. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osyris's devices?
Among its 3 most recently registered devices, Osyris has devices listed in FDA 510(k) (3 devices).
What risk classes do Osyris's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Osyris's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Osyris in the registry?
The most recently registered devices listed for Osyris include SMOOTHKIT+, PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE and PHARAON LIPO.