Good news
Beijing Chunli Zhengda Medical Instruments Co., Ltd.’s “Dental Polymer - based Composite Resin” Obtains Medical Device Registration Approval
Product Introduction
Dental polymer-based composite resin is an intraoral restorative material that cures directly in the oral cavity upon exposure to an external light source. Composed of a resin matrix and inorganic fillers, the material undergoes a curing reaction and subsequent shaping when exposed to visible light at a wavelength of 450–500 nm. After contour modification and polishing, it is used for filling and restoring tooth defects. Featuring a wide range of color options with shades closely mimicking natural dental tissues, high strength post-curing, and robust adhesive retention, it is one of the most commonly used intraoral restorative materials.
This product is indicated for the filling and restoration of tooth defects, including:
（1）Defects on the occlusal surfaces or incisal edges of posterior teeth;
（2）Class III cavities (G.V. Black classification);
（3）Class V cavities on the crown portion.
Product Advantages
1.Aesthetic Performance: Excellent polishability delivers a smooth surface for the restoration, closely mimicking the visual appearance and tactile feel of natural teeth. Available shades include A1, A2, A3, A3.5, B1, B2, and M1 (VITA Classical Shade Guide compliant).
2.High Mechanical Strength: With a flexural strength of ≥ 120 MPa and a compressive strength of ≥ 290 MPa, the restoration can withstand various mechanical loads during mastication, ensuring excellent durability.
3.Low Polymerization Shrinkage: A polymerization shrinkage of less than 2.2% helps reduce micro - gaps that may occur after restoration, lowers the risk of secondary caries, and enhances the long - term stability of the restoration
4.Broad Applicability: It is capable of restoring both anterior/posterior teeth and dentin/enamel.
5.Excellent Handling Properties: A depth of cure of ≥ 3 mm, combined with easy curing, non - stick instruments, and easy shaping.
Product operation process
1.Isolation: Rubber dam isolation is recommended.
2.Cavity Preparation: Cavity preparation shall follow the principle of minimal invasion of dental hard tissues.
3.Pulp Protection: Calcium hydroxide paste is recommended for cavity lining.
4.Shade Selection: Select shades using dedicated dental shade guides or the VITA Classical Shade Guide.
5.Acid Etchant Application: Apply etchant (maintain for 60 seconds), followed by water rinsing and air drying.
6.Adhesive Application: Apply dental resin adhesive, blow gently with air, and cure with light irradiation for 10 seconds.
7.Filling and Curing of Dental Polymer-based Composite Resin: Fill the cavity with the resin and perform light curing (with irradiation time adjusted based on cavity depth).
8.Contouring and Polishing: Contouring can be performed with diamond burs, while polishing can be done with white stone burs and silicone burs.
Company Introduction
Beijing Chunlizhengda Medical Instruments Co., Ltd. (hereinafter referred to as "Chunli Medical"), founded in 1998, is mainly engaged in the R&D, production, and sales of medical devices such as orthopedic, dental, biomedical materials, and surgical robots. After nearly three decades of development, Chunli Medical has become the only A+H - listed enterprise in China's orthopedic and dental sectors. It boasts national - level R&D platforms including the National Enterprise Technology Center and the National Postdoctoral Research Station, and holds prestigious titles such as National Manufacturing Single Champion Enterprise, National High - tech Enterprise, National "Little Giant" Enterprise of Specialization, Sophistication, Unique Products and New Technologies, National Intellectual Property Advantage Enterprise, and Zhongguancun High - tech Enterprise. The company leads two National Key R&D Programs and is the only domestic enterprise that has extensively applied tantalum metal in dental, joint, spinal, and sports medicine products. It also takes the lead in four "Challenges - based Bidding" projects of the Ministry of Industry and Information Technology, promoting the industrialization of magnesium alloys, hydroxyapatite, and tantalum metal and their clinical applications in the domestic dental field. In addition, its "Challenges - based Bidding" project on surgical robots has been accredited as an "Excellent Unit", accelerating the R&D and clinical promotion of domestic surgical robots.
Adhering to the R&D and production philosophy of "Chunli Dental, Craftsmanship - driven Manufacturing", Chunli Medical has established a one - stop comprehensive dental solution system, covering orthodontics, dental implantation, prosthodontics, maxillofacial surgery, and surgical robots, making it one of the brands with the most complete dental product lines in the market. Guided by the corporate philosophy of "Inheriting the essence of predecessors and developing high - quality products for the world" and the quality policy of "Treating products as if for personal use and pursuing continuous innovation", the company strictly controls the quality of its dental products. Leveraging national - level platforms and projects, it adheres to in - depth collaboration among industry, academia, research, medical institutions, and testing bodies to develop dental products tailored to the characteristics of Chinese people. It is committed to providing high - quality products to global customers and striving to become a world - renowned dental enterprise.
