FDA 510(k) Application Details - K214118

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K214118
Device Name	Cement, Dental
Applicant	SDI Limited 3-15 Brunsdon Street Bayswater 3153 AU Other 510(k) Applications for this Company
Contact	Antonella Kotefski 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	12/30/2021
Decision Date	08/30/2022
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