Satelec - Acteon, Inc.
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- Devices
- 1
What Satelec - Acteon, Inc. makes
Satelec - Acteon, Inc. manufactures the Piezotome Solo, a piezoelectric surgical device designed for precise bone cutting in dental and maxillofacial procedures. This device uses ultrasonic vibrations to reshape bone with minimal trauma, reducing the risk of thermal damage or soft tissue injury. It is intended for applications such as sinus lifts, ridge augmentation, and implant site preparation.
The Piezotome Solo is classified as a Class II medical device under FDA regulations and is authorised through the 510(k) clearance process. The company is based in the United States. Device listings are maintained in the FDA’s 510(k) registry.
Catalogue
Piezotome Solo Ref K112188
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Satelec - Acteon, Inc. have in the registry?
The registry currently lists 1 device for Satelec - Acteon, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Satelec - Acteon, Inc.'s devices?
Among its 1 most recently registered device, Satelec - Acteon, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Satelec - Acteon, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Satelec - Acteon, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Satelec - Acteon, Inc. in the registry?
The most recently registered devices listed for Satelec - Acteon, Inc. include PIEZOTOME SOLO.