FDA 510(k) Application Details - K190569

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K190569
Device Name	Powder, Porcelain
Applicant	Digital Age Dental Lab 2110 Artesia Blvd, Ste. B-132 Redondo Beach, CA 90278 US Other 510(k) Applications for this Company
Contact	Tim McKimson 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	03/06/2019
Decision Date	07/29/2019
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