Coex i500 - PMDA ID 830029_30100BZX00079000_A_01_02
Access comprehensive regulatory information for Coex i500 (コエックス ｉ５００) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 830029_30100BZX00079000_A_01_02 and manufactured by Yoshida Co., Ltd.. The device information was last updated on April 27, 2021.
This page provides complete registration details including device class (A6001), classification (digital impression taker / デジタル印象採得装置), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.
This product optically captures the impression of the oral cavity. In addition to being used for medical treatment and patient explanation, the acquired 3D images are sent to computer-aided design (CAD) and computer-aided manufacturing (CAM) for use in the design and manufacture of shapes of dental restorations, dental prostheses, etc. In addition, dental and dentition models, dental restorations and prosthetics may be used in the dental laboratory by optical impression acquisition.
本品は光学的に口腔内の印象採得する。採得した三次元画像を診療及び患者説明に用いるほか、コンピュータ支援設計（CAD）及びコンピュータ支援製造（CAM）に送信して、歯科修復物、歯科補綴物等の形状の設計及び製造に用いる。また、歯科技工室で歯牙・歯列模型、歯科修復物や補綴物を光学的に印象採得して用いることもある。