What Category of Medical Device does a Dental Chair Belong to?

The exchange of old DYM dental chairs for new ones shares with you which categories of medical device does a dental chair used in dental clinics belong to? There are many types of dental chairs. The following is a detailed classification of dental chairs based on their different functions:

1. Dental Chairs are Categorized as Basic Mechanically Adjustable Dental Chairs.

These dental chairs only feature basic mechanical adjustment functions, relying on manual or other mechanical means to achieve simple lifting and tilting movements. Their simple structure and low user risk meet the criteria for Class I medical devices and are therefore classified as Class I medical devices. They are suitable for daily routine functions such as animal dentistry, dental education and cosmetic examinations.

2. Hydraulically Driven Dental Chairs.

Hydraulic dental chairs utilize hydraulic drive to achieve precise height and tilt adjustments. Compared to basic mechanically adjustable dental chairs, their structure is more complex and potentially carries a higher risk. They are classified as Class II medical devices and require legal registration and certification of compliance before they can be manufactured, sold, and used.

3. Electric Drive Dental Chairs.

Basic electric dental chairs utilize electric drive to achieve precise height, tilt, and rotation adjustments. While they do not integrate numerous diagnostic and treatment support systems, their more complex structure and potential risk are higher than mechanical dental chairs. Therefore, they are classified as Class II medical devices and require registration before they can be marketed.

4. Dental Unit with Integrated Lighting System.

This unit is powered by an electric or hydraulic drive and integrates the lighting system required for treatment. It provides adequate and appropriate lighting, facilitating dental procedures. Its complex functions and high level of integration pose higher risks than basic dental chairs. It is a Class II medical device and must be registered and certified for production, sale, and use.

5. Dental Unit with Integrated Saliva Aspiration System.

In addition to its electric or hydraulically driven, precise adjustment capabilities, this unit also incorporates a saliva aspiration system to promptly remove saliva and waste fluids from the patient’s mouth during treatment, enhancing comfort and safety. Due to its complex structure and high level of functional integration, it carries significant potential risks and is therefore a Class II medical device, requiring registration.

6. Dental Unit with Integrated Flushing System.

This unit features an integrated flushing system during dental treatment. Combined with electric or hydraulically driven, precise positioning, it meets the needs of various dental treatment scenarios. Its complex functions and the involvement of auxiliary procedures pose a higher potential risk. It is a Class II medical device and requires registration for production, sale, and use.

7. High-end Dental Comprehensive Treatment Units Integrating Multiple Diagnosis and Treatment Auxiliary Systems (oral lighting + strong and weak saliva suction + flushing function).

This high-end dental unit integrates multiple diagnostic and treatment assistance systems, including oral lighting, saliva suction, and flushing. It utilizes electric or hydraulic drive for highly precise positioning, making it suitable for complex dental treatment scenarios. Its extremely complex structure and high level of functional integration present significant potential risks. As a Class II medical device, it must be legally registered and certified before production, sales, and use.

The DYM dental chair is a Class II medical device and holds a Class II registration certificate issued by the Guangdong Food and Drug Administration. The company has ISO9001, ISO3485, and CE certifications. The chair has a 15-year service life and comes with a two-year warranty. One to three technical inspections are provided annually, providing peace of mind for dental institutions and clinics. DYM currently collaborates with 35,000 dental institutions across China, earning dentists’ praise for its product quality and dedicated service.