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National Food and Drug Administration: Oral implant surgery navigation and positioning equipment approved for marketing

 Last Update: 2021-09-19
 Source: Internet
 Author: User

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Recently, the National Medical Products Administration approved the registration application of the innovative product "Oral Implant Surgery Navigation and Positioning Device" produced by Yake Wisdom (Beijing) Technology Co.
, Ltd.
after review
.

This product consists of a motor holder, an implant cart, a vision and display cart, and surgical navigation software; it is used in conjunction with supporting accessories for the navigation and positioning of implants during adult oral implant surgery
.

This product is the first domestic medical device with independent intellectual property rights
.
The core technologies include spatial mapping, surgical path planning and surgical path positioning, and have patents for the registration method and electronic equipment of dental implant surgery visual navigation, implant mobile phone holding device, oral implant surgery positioning device and surgical path planning method
.
The clinical advantage of this product is mainly to ensure the accuracy of implant placement
.

The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients with equipment
.

　　Attachment: Innovative medical devices approved by the State Food and Drug Administration

　　List of innovative medical device products approved by the State Food and Drug Administration.
docx

　　The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients with equipment
.

　　Attachment: Innovative medical devices approved by the State Food and Drug Administration

　　List of innovative medical device products approved by the State Food and Drug Administration.
docx

Medical equipment medical equipment

　　The drug supervision and administration department will strengthen the post-market supervision of the product to protect the safety of patients with equipment
.

Medicine medicine

　　Attachment: Innovative medical devices approved by the State Food and Drug Administration

　　List of innovative medical device products approved by the State Food and Drug Administration.
docx

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