FDA 510(k) Application Details - K150872

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K150872
Device Name Powder, Porcelain
Applicant PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DRIVE
SUITE P
IRVINE, CA 92612 US
Other 510(k) Applications for this Company
Contact ARMIN ZEHTABCHI
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 04/01/2015
Decision Date 07/02/2015
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact