FDA 510(k) Application Details - K250223

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K250223
Device Name	Powder, Porcelain
Applicant	Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	So Hyun Park 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	01/27/2025
Decision Date	02/25/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review