Dental implant systems
- Device class
- Class III
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20253170287
- Approval date
- January 26, 2025
- Expiry date
- January 25, 2030
- Name
- Beijing Chunlizhengda Medical Instruments Co., Ltd.北京市春立正达医疗器械股份有限公司
- Province/Region
- Beijing北京
- Address
- No. 10, Xinmi West 2nd Road, South District, Tongzhou Economic Development Zone, Tongzhou District, Beijing北京市通州区通州经济开发区南区鑫觅西二路10号
- Production address
- 北京市通州区通州经济开发区南区鑫觅西二路10号
The product is surgically implanted into the alveolar bone of the upper and lower jaws in the missing part of the human tooth to provide fixation or support for restorations such as dentures to restore the patient's chewing function.
通过外科手术方式将产品植入人体缺牙部位的上下颌牙槽骨内，用于为义齿等修复体提供固定或支撑，以恢复患者的咀嚼功能。
本产品由牙种植体、覆盖螺钉及携带体组成。牙种植体为骨水平种植体。牙种植体、覆盖螺钉采用符合GB/T 13810的纯钛（TA4G）制成，表面喷砂酸蚀处理。携带体采用钛合金（TC4ELI）制成，表面未经任何处理。产品以无菌状态交付，辐照灭菌，灭菌有效期为5年。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Dental implant systems in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20253170287 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on January 26, 2025.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.