FDA 510(k) Application Details - K233125

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K233125
Device Name	Powder, Porcelain
Applicant	Hangzhou IVISTA Medical Devices Co., Ltd. No. 7, Chunjiang Road, Qiaonan Development Zone Ningwei Town, Xiaoshan District Hangzhou 311217 CN Other 510(k) Applications for this Company
Contact	Yao Cheng Other 510(k) Applications for this Contact
Regulation Number	872.6660   More FDA Info for this Regulation Number
Classification Product Code	EIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2023
Decision Date	01/12/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review