NAKAMURA DENTAL K.K.

Nakamura Dental K.K. specializes in dental power tool attachments, specifically devices used for drilling procedures. Their primary product is a straight handpiece, which is designed for precision cutting or drilling in routine dental operations. These tools are essential for tasks requiring controlled removal of dental material, such as cavity preparation or tooth reduction.

Nakamura Dental K.K. is headquartered in the United States. The company’s location in the US may influence regulatory pathways and compliance requirements for its devices, though individual device authorization depends on the specific regulatory body’s evaluation criteria.

Nakamura Dental K.K.’s devices are listed in the FDA’s Unique Device Identification (UDI) system. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for healthcare providers and regulators. Listing in the UDI system is a requirement for Class I devices in the US.

Nakamura Dental K.K.’s devices fall under Class I classification in the US regulatory framework. Class I devices are generally considered to pose the lowest risk and often require less stringent premarket review, such as compliance with general controls (e.g., proper labeling, manufacturing practices) rather than a formal approval process. The classification is determined by factors like the device’s intended use and potential risk to patients.