Hasharon Dental Center Ltd.

Hasharon Dental Center Ltd. specializes in diamond-coated dental burs. These burs are engineered for precision cutting and shaping in dental procedures, such as cavity preparation, crown and bridge work, and other restorative treatments that require high-speed, durable abrasion. The design focuses on efficiency and durability in clinical settings.

Hasharon Dental Center Ltd. is based in Israel. The company develops and lists its diamond-coated dental burs from this location, ensuring compliance with relevant regional regulations. While the country of origin may influence regulatory pathways, the specific classification and registration of the devices depend on their intended use and risk level, not the manufacturer’s location alone.

Hasharon Dental Center Ltd.’s diamond-coated dental burs are registered in the eudamed database, which is the EU’s centralised registry for medical devices. This registration is required for devices placed on the European market, ensuring transparency and traceability as part of the EU’s regulatory framework.

Under EU medical device regulations, Hasharon Dental Center Ltd.’s diamond-coated dental burs are classified as Class IIa. This classification is determined by their intended use—specifically, their role in cutting and shaping dental structures during procedures like restorations. Class IIa devices pose a moderate risk and require compliance with specific design controls and conformity assessment procedures before market placement.