FDA 510(k) Application Details - K160493

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K160493
Device Name	Barrier, Synthetic, Intraoral
Applicant	Salvin Dental Specialties 3450 Latrobe Drive Charlotte, NC 28211 US Other 510(k) Applications for this Company
Contact	Jennifer Singer Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2016
Decision Date	09/08/2016
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