Satelec - Acteon Group
Country not established FDA
- Devices
- 12
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Satelec - Acteon Group makes
The company manufactures dental devices for endodontic and ultrasonic procedures, including LED curing lights (e.g., SCANWAVE pens), endodontic motors (e.g., I-ENDO DUAL), and ultrasonic surgical tools (e.g., PROULTRA PIEZO ULTRASONIC). It also produces LED dental curing units (e.g., NEWTRON P5, NEWTRON P5 XS B.LED) and implant planning software (e.g., IMPLANT CENTER). Additional products include endodontic treatment units (e.g., ENDOCENTER) and LED corded devices for dental applications.
These devices are regulated under FDA 510(k) clearance, with classifications spanning Class I and Class II. The portfolio is listed in the FDA’s 510(k) registry, and the company operates from the United States.
Catalogue
Search and filter all 12 devicesFDA establishments
- Satelec-Acteon Group MERIGNAC Gironde · FR FEI 3004536551
Frequently asked questions
How many devices does Satelec - Acteon Group have in the registry?
The registry currently lists 12 devices for Satelec - Acteon Group. Devices recorded under merged duplicate company entries are counted once.
Which registries list Satelec - Acteon Group's devices?
Among its 12 most recently registered devices, Satelec - Acteon Group has devices listed in FDA 510(k) (12 devices).
What risk classes do Satelec - Acteon Group's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Satelec - Acteon Group's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Satelec - Acteon Group in the registry?
The most recently registered devices listed for Satelec - Acteon Group include SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE, I-ENDO DUAL, NEWTRON BOOSTER and IMPLANT CENTER.
Which FDA establishments are linked to Satelec - Acteon Group?
1 FDA establishment is linked to Satelec - Acteon Group in the registry; they are listed on the company page.