510(k) K233125

Zirconia Block by Hangzhou Ivista Medical Devices Co., Ltd. — Product Code EIH

K233125 is an FDA 510(k) premarket notification submitted by Hangzhou Ivista Medical Devices Co., Ltd. for the device "Zirconia Block". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.