FDA 510(k) Application Details - K141504

Device Classification Name	Unit, Operative Dental   More FDA Info for this Device
510(K) Number	K141504
Device Name	Unit, Operative Dental
Applicant	THEROZONE USA, INC. 2701 OCEAN PARK BLVD, SUITE 108 SANTA MONICA, CA 90405 US Other 510(k) Applications for this Company
Contact	Rebecca K Pine Other 510(k) Applications for this Contact
Regulation Number	872.6640   More FDA Info for this Regulation Number
Classification Product Code	EIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2014
Decision Date	02/24/2015
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