FDA 510(k) Application Details - K160979

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K160979
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P IRVINE, CA 92612 US Other 510(k) Applications for this Company
Contact	SHELLY HARRIS Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2016
Decision Date	11/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review