Dentsply Gendex
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- Devices
- 1
What Dentsply Gendex makes
Dentsply Gendex manufactures intraoral and extraoral cephalometric X-ray systems, including the Orthoralix 9200 DDE and its cephalometric variant, designed for dental and orthodontic imaging. These devices capture detailed images of the jaw, teeth, and surrounding structures to aid in treatment planning and diagnostics. Additional models, such as the 5105 series, support specialized imaging applications in dental radiography.
The company’s cephalometric X-ray systems fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance via the FDA. These devices are listed in the FDA’s 510(k) database under dental radiography equipment. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dentsply Gendex have in the registry?
The registry currently lists 1 device for Dentsply Gendex. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentsply Gendex's devices?
Among its 1 most recently registered device, Dentsply Gendex has devices listed in FDA 510(k) (1 device).
What risk classes do Dentsply Gendex's devices fall under?
Among its 1 most recently registered device, the classes recorded for Dentsply Gendex's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dentsply Gendex in the registry?
The most recently registered devices listed for Dentsply Gendex include ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW.