Guideline for registration unit division of dental implants

Definition

A dental implant is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis such as a crown, bridge, denture, facial prosthesis or to act as an orthodontic anchor.

Classification

In the newest Medical Device Classification Catalog (CFDA 2017 No. 104), the classification code of dental implants is 17-08-01 Class III medical device. Dental implants are under the sub-category ‘Dental Equipment’. The first category is ‘oral implantation and tissue reconstruction materials’ and the second category is ‘dental implant’. The product description is ‘Stud or other solid shape. It is usually made of metal, including titanium, titanium alloy, tantalum, etc. It can also be made of other materials such as ceramics. It is surgically implanted into the upper and lower jaws of the edentulous part of the human body’. The intended use is that the dental implants are implanted into the alveolar bone to provide fixation or support for the prosthesis, etc., to restore the patient's chewing function. It is not in the Medical Device Catalog Exempted from Clinical Trials (NMPA 2018 No. 94), which means clinical trials are required for registration in China.

Guideline of registration unit division

1. The implants with different body materials should be divided into different registration units;

2. The implants with different surface treatment methods should be divided into different registration units;

3. The implants with different composition should be divided into different registration units;

4. The implants with different molding processes should be divided into different registration units.

5. An implant system that must be used in combination to achieve its intended use can be declared as one registered unit.

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