Dentsply DeTrey GmbH

Dentsply DeTrey GmbH specializes in dental medical devices, primarily calcium hydroxide dental cements and dental composite resins. Their calcium hydroxide products include tube-based formulations like AH PLUS and AH PLUS NEO, as well as starter kits and refills for jet application systems. ChemVarnish is an example of their dental composite resin, used for dental restorations.

The company is headquartered in Germany, specifically as Dentsply DeTrey GmbH, which aligns with its regulatory and operational base for manufacturing and distributing its dental devices.

Dentsply DeTrey GmbH’s devices are listed in the eudamed database, which is the European Union’s central registry for medical device information. This registry ensures transparency and traceability of devices authorized under EU regulations.

The company’s devices fall into Class I and Class IIa classifications under EU medical device regulations. Class I devices are generally low-risk, while Class IIa devices pose a slightly higher risk and require additional conformity assessments, such as clinical evaluations or performance studies, to ensure safety and performance.