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Dentsply Intl.

Also registered as Dentsply Intl., Inc.

Country not established

Devices
291

What Dentsply Intl. makes

Dentsply Intl. manufactures dental instruments and materials for endodontic, restorative, and preventive procedures, including sterile endodontic files, pit-and-fissure sealants, fluoride varnishes, ultrasonic scaler systems, root canal filling resins, temporary cements, and model tray materials. Their portfolio also includes root canal therapy gels, precision torque systems for dental implants, and direct-delivery fluoride systems for cavity prevention.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue291

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Frequently asked questions

How many devices does Dentsply Intl. have in the registry?

The registry currently lists 291 devices for Dentsply Intl.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Dentsply Intl.'s devices?

Among its 50 most recently registered devices, Dentsply Intl. has devices listed in FDA 510(k) (50 devices).

What risk classes do Dentsply Intl.'s devices fall under?

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

What are the newest devices from Dentsply Intl. in the registry?

The most recently registered devices listed for Dentsply Intl. include DISPOSABLE SCREW TYPE PROPHY BRUSH, STERILE FLEXOFILE FILES AND INSTRUMENTS, DELTON F PIT & FISSURE SEALANT and FLUORIDE VARNISH.

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