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Dental implant abutment system - NMPA Registration 国械注准20243172260

Access comprehensive regulatory information for Dental implant abutment system 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20243172260 and owned by Beijing Chunlizhengda Medical Instruments Co., Ltd.. The device was approved on December 17, 2024.

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.

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Class III
国械注准20243172260
Dental implant abutment system
牙种植体基台系统
NMPA Registration Number: 国械注准20243172260
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Pricing
Intended Use
English

This product is a companion component to dental implants implanted in the jawbone after tooth loss to connect, support and retain restorations.

中文

该产品为牙缺失后颌骨内植入的牙种植体的配套用部件,用于连接、支持和固位修复体。

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20243172260
Approval Date
December 17, 2024
Expiry Date
November 20, 2029
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

该产品由基台、基底和螺丝组成,产品由符合GB/T 13810标准规定的钛合金TC4ELI材料制成,表面无任何处理,部分产品灭菌包装,产品经辐照灭菌,灭菌有效期5年.

中文

该产品由基台、基底和螺丝组成,产品由符合GB/T 13810标准规定的钛合金TC4ELI材料制成,表面无任何处理,部分产品灭菌包装,产品经辐照灭菌,灭菌有效期5年。

Additional Information
Remark
2024年12月17日同意更正型号规格列表相关内容,2024年11月21日核发的中华人民共和国医疗器械注册证及型号规格列表予以废止。
Appendix
产品技术要求