Nakanishi, Inc. - FDA 510(k) Cleared Devices

Nakanishi, Inc. is a precision medical device manufacturer based in Kanuma, Japan. The company specializes in motorized spindles and micro grinders for medical and industrial applications.

Nakanishi has received 40 FDA 510(k) clearances from 40 total submissions since its first clearance in 2001. Dental devices represent the dominant category, accounting for 88% of the company's regulatory submissions. The company remains active, with its latest FDA 510(k) clearance in 2026.

Recent cleared devices include motorized systems for dental surgery and scaling, air-powered polishing instruments, and precision cutting tools. The company's product portfolio reflects deep expertise in rotary and ultrasonic technologies for clinical and surgical applications.

Explore the complete list of device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Ken Block Consulting, LLC, Regulatory Technology Services, LLC and Globizz Corporation.