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Dentsply Sirona Inc

Also registered as Dentsply Sirona

Country not established FDA establishment FEI 3004884150

Devices
88
Registrations
FDA
FDA recalls
0

What Dentsply Sirona Inc makes

DENTSPLY SIRONA INC manufactures the X-Smart Pro device, which is a Class I medical device.

The company is based in the US and its devices are listed in the FDA 510(k) registry.

AI-generated from registry data, 4 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number
3004884150
Address
221 W Philadelphia St Ste 60w, York, PA, 17401

Frequently asked questions

How many devices does DENTSPLY SIRONA INC have in the registry?

The registry currently lists 88 devices for DENTSPLY SIRONA INC. Devices recorded under merged duplicate company entries are counted once.

Which registries list DENTSPLY SIRONA INC's devices?

Among its 50 most recently registered devices, DENTSPLY SIRONA INC has devices listed in FDA 510(k) (50 devices).

What risk classes do DENTSPLY SIRONA INC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for DENTSPLY SIRONA INC's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from DENTSPLY SIRONA INC in the registry?

The most recently registered devices listed for DENTSPLY SIRONA INC include DS Core CBCT Anatomy, Surgical and Prosthetic Trays, X-Smart Pro and Sirona Dental CAD/CAM System with CEREC Chairside Software.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company and no recalls are recorded.