On December 14, 2022, the dental laser selective melting cobalt chromium alloy powder product CoCr01 independently developed by Avimetal was reviewed and approved by the National Drug Administration, successfully obtaining the registration certificate for Class III medical devices, completing the final hurdle and launching sales services, officially entering the dental metal additive manufacturing industry.

Medical device registration certificate refers to the legal ID card of medical device products (including medical equipment and medical consumables).

Medical device registration is divided into domestic and overseas categories, and is divided into three categories based on the registration process, production process, and business license. The first and second categories of medical devices in China are handled by the local provincial or municipal Food and Drug Administration, while the third category is reviewed and approved by the State Food and Drug Administration, and a medical device registration certificate is issued after approval.

The third type of medical device is a medical device with high risks and requires special measures to strictly control and manage it to ensure its safety and effectiveness. It is the highest level of medical device and has strict regulatory measures for the production and operation activities of the product.

In 2017, Avimetal began the research and development and registration of laser selective melting alloy powders for dentistry; During this period, a large batch of powder performance validation was conducted for product application scenarios, including printing cycle times, fatigue tests for removable partial dentures, friction and wear tests, etc.

Microscopic morphology after 20 cycles of use

Internal porosity of optimized printing structure

After 5 years of repeated and rigorous innovation and polishing, a laser selective melting cobalt chromium alloy powder product CoCr01 was prepared that meets the requirements of dental application scenarios. The powder has passed clinical use simulation tests and has excellent antioxidant, corrosion and fatigue resistance.

Introduction to CoCr01

CoCr01 (CoCrMoW) powder is a type of cobalt chromium alloy powder, which mainly adds elements such as Mo and W on top of Co and Cr, and contains a small amount of Si, Fe, etc. It has oxidation resistance and corrosion resistance.

CoCr01 Preparation Technology

CoCr01 Application Scenario

Mainly used in the field of medical devices, processing metal dentures and brackets, etc.

Basic performance indicators of CoCr01

Clinical performance testing

At present, in accordance with YY/T 0287-2017 and the “Quality Management Standards for Medical Device Production”, Avimetal has established a strict quality management system for the dental application industry, and has built a complete and large-scale powder making workshop, screening workshop, application verification production line, and testing laboratory, which can continuously provide high-quality product services to industry customers.

Metal 3D printing technology has developed rapidly in the field of medical devices due to its advantages in personalized complex structures, biomimetic structures, porous structures, lightweight structures, personalized customization, and one-step forming; Dental metal 3D printing technology has been a hot track in the medical device industry in recent years, and it is also a key product and service field deeply cultivated by Avimetal.

This time, Avimetal CoCr01 has obtained a Class III medical device registration certificate, which is of great significance as the first pass for the company to enter the dental market; In the future, Avimetal will vigorously promote the research and development, registration, and other series of powder materials such as dental titanium and titanium alloys, cobalt chromium alloys, and continue to empower the industry’s development.