FDA 510(k) Application Details - K242407

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K242407
Device Name	Powder, Porcelain
Applicant	Hunan Vsmile Biotechnology Co., Ltd. Room.1202-1203, Huanchuang Enterprise Square Building A4 No.2450 Yuelu West Avenue Hi-tech Development District Changsha 410000 CN Other 510(k) Applications for this Company
Contact	Xiaomi Tang 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	08/14/2024
Decision Date	11/13/2024
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