The machine root canal file has won the domestic second-class NMPA registration certificate!

Mechanical root canal file is a dental rotary instrument that needs to be used in conjunction with a dental mobile phone to provide power. The machine used root canal file consists of a handle and a head working end. The body of the file is made of nickel titanium alloy, and the working end has grooves or spiral cutting edges. It is used for root canal preparation, auxiliary filling (i.e. cutting, leveling, cleaning, and shaping of dental bones, root canals, etc.) in dental treatment. The machine root canal file consists of an operating part and a rod, with a working part with a cutting edge on the operating part; The operating part is made of nickel titanium alloy material.


Target users: The product must be used by dentists who have received formal training in root canal treatment. The expected usage location of this product is medical institutions, dental clinics, and similar occasions.



Our company was commissioned by the client to handle the first registration of NMPA Class II medical devices for their company's machine root canal files at the end of December 2021. After 7 months, Rui Enni lived up to the customer's expectations and received the registration certificate approval on July 1, 2022. (Approval date: June 29, 2022, registration certificate number: Yue Xie Zhu Zhun 20222170852)




After this registration, I have a few experiences to share with you:




1) [Sensitive words] Step, first classify the root canal files according to their shape. The types of mechanical root canal files are complex, and according to their shape and taper, they can be classified into standard instruments, tapered instruments, molded instruments, non tapered instruments, and non single tapered instruments. The standard requirements corresponding to different classifications are also different.




2) The second step is to carefully identify the type of root canal file within the applicable standards. Even for the same standard, each standard chapter should be carefully differentiated based on the different types of root canal files.




3) Overall, from a professional perspective in the field of mechanical root canal filing, there are many shortcomings in the YY0803 sequence standard applicable to root canal filing. In terms of some content, most of the products that have already been launched do not actually meet some of the requirements of the YY0803 sequence standard. From the perspective of the reviewing teacher, mandatory requirements must be met. So, how to solve these contradictory problems is currently the challenge we are facing.




4) There are many models and specifications of root canal files registered this time, with 56 registered models, and dozens of specifications are subdivided for different models. The product testing and issuance of test reports are also very patient tests. When testing at the provincial institute, the institute considers the model specifications to be large and is only willing to provide test reports for three main inspection models. All other models with differences in specifications need to be provided by the manufacturer themselves. Fortunately, due to policy changes, the drug regulatory authority can recognize the self testing reports of enterprises. This greatly saves product testing time.




In summary, the NMPA registration of root canal files needs to focus on the compliance of standard terms and the consistency of similar compared products.