FDA 510(k) Application Details - K181110

Device Classification Name	Handpiece, Air-Powered, Dental   More FDA Info for this Device
510(K) Number	K181110
Device Name	Handpiece, Air-Powered, Dental
Applicant	Kaltenbach & Voigt GmbH Bismarckring 39 Biberach 88400 DE Other 510(k) Applications for this Company
Contact	Stefan Trampler Other 510(k) Applications for this Contact
Regulation Number	872.4200   More FDA Info for this Regulation Number
Classification Product Code	EFB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2018
Decision Date	04/10/2019
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