FDA 510(k) Application Details - K180682

Device Classification Name	Handpiece, Direct Drive, Ac-Powered   More FDA Info for this Device
510(K) Number	K180682
Device Name	Handpiece, Direct Drive, Ac-Powered
Applicant	Premier Dental Company Products 1710 Romano Drive Plymouth Meeting, PA 19462 US Other 510(k) Applications for this Company
Contact	Noel Hetrick Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EKX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2018
Decision Date	02/27/2019
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