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2025/11/11
Requirements under the EU Medical Device Regulation (MDR 2017/745)
Under the European Union Medical Device Regulation (MDR 2017/745), dental handpieces must obtain CE certification before being marketed in the EU. Manufacturers must ensure compliance with Annex I’s General Safety and Performance Requirements (GSPR), covering product design, material safety, noise level, and sterilization performance. A comprehensive Quality Management System (QMS) and post-market surveillance plan must also be implemented.
2025/11/11
Excerpt from the Regulations on the Supervision and Administration of Medical Devices (China)
According to the Regulations on the Supervision and Administration of Medical Devices of the People’s Republic of China, dental handpieces are classified as Class II medical devices. They must be registered or filed with the National Medical Products Administration (NMPA) before entering the market. Manufacturers must ensure compliance with national standard YY/T 0648-2016 (Dental Handpieces) and ISO 7785-1 international requirements.
2025/11/11
Analysis of Torque Control and Noise Reduction in Low-Speed Dental Handpieces
This paper focuses on torque stability and noise reduction in low-speed dental handpieces used for endodontic and prosthetic treatments. By optimizing the gear transmission structure and integrating micro-damping pads, noise levels were reduced by about 25%, and torque fluctuation was controlled within ±3%. This technology improves both comfort and precision during clinical procedures, ensuring stable power delivery.
2025/11/11
Optimization Study on Rotational Speed and Cooling System of High-Speed Dental Handpieces
This study investigates the efficiency of cooling systems in high-speed dental handpieces under high rotational speeds. By comparing different spray hole structures, bearing materials, and airflow channel designs, results show that the optimized triple-spray cooling system can reduce head temperature by approximately 15%, significantly extend bearing life, and enhance operational stability. The findings provide new insights into structural optimization and thermal management for dental handpieces.
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