FDA 510(k) Application Details - K240419

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K240419
Device Name	Powder, Porcelain
Applicant	Boston Micro Fabrication 8 Mill & Main Suite 310 Maynard, MA 01754 US Other 510(k) Applications for this Company
Contact	John Kawola 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	02/13/2024
Decision Date	04/12/2024
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