FDA 510(k) Application Details - K241316

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K241316
Device Name	Powder, Porcelain
Applicant	Hunan Hualian Special Ceramics Co., Ltd. Hunan Province Liling Economic Development Zone Innovation Park II Liling CN Other 510(k) Applications for this Company
Contact	Fusheng Chen 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	05/10/2024
Decision Date	07/09/2024
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