FDA 510(k) Application Details - K210884

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K210884
Device Name	Powder, Porcelain
Applicant	1Derful, Inc 38345 Donigan Road Brookshire, TX 77423 US Other 510(k) Applications for this Company
Contact	Mohamad Alkassab 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	03/25/2021
Decision Date	07/27/2021
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