Oxide zirconia color ceramic block for all-ceramic denture - NMPA Registration 鲁械注准20242170878
Access comprehensive regulatory information for Oxide zirconia color ceramic block for all-ceramic denture in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242170878 and owned by Shinva Medical Instrument Co., Ltd.. The device was approved on September 20, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.
This product is suitable for making crowns, bridges, inlays and veneers of dental fixed teeth of three units or less.
本产品适用于制作三单位及三单位以下的牙科固定义齿的冠、桥、嵌体、贴面。
主要由氧化锆及氧化铒,氧化铁和其他氧化物组成. 其中氧化锆(含氧化铪、氧化钇)(ZrO2+HfO2+Y2O3):≥99%;氧化钇(Y2O3):4.0%～10.0%;氧化铪(HfO2):≤5%;氧化铝(Al2 O3):≤0.5%;氧化铁(Fe2O3)≤1.0%;氧化铒(Er2O3)≤1.0%;其他氧化物:≤0.5%.
主要由氧化锆及氧化铒，氧化铁和其他氧化物组成。其中氧化锆（含氧化铪、氧化钇）（ZrO2+HfO2+Y2O3）：≥99%；氧化钇（Y2O3）：4.0%～10.0%；氧化铪（HfO2）：≤5%；氧化铝（Al2 O3）：≤0.5%；氧化铁（Fe2O3）≤1.0%；氧化铒（Er2O3）≤1.0%；其他氧化物：≤0.5%。