Pure Global

Dental implant systems - NMPA Registration 国械注准20253170287

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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20253170287
Dental implant systems
牙种植体系统
NMPA Registration Number: 国械注准20253170287
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

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.

中文

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。

Device Classification
Device Class
Class III
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253170287
Approval Date
January 26, 2025
Expiry Date
January 25, 2030
Registrant
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 Facility
Production Address
北京市通州区通州经济开发区南区鑫觅西二路10号
Structure and Composition
English

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。

Additional Information
Appendix
产品技术要求