FDA 510(k) Application Details - K241204

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K241204
Device Name	Cement, Dental
Applicant	Rizhao HuGe Biomaterials Company, Ltd. No.2 North Zhaoyang Road, District of Donggang Rizhao City 276800 CN Other 510(k) Applications for this Company
Contact	Maggie Zheng Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2024
Decision Date	06/28/2024
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