FDA 510(k) Application Details - K153048

Device Classification Name	More FDA Info for this Device
510(K) Number	K153048
Device Name	AcceleDent Aura
Applicant	ORTHOACCEL TECHNOLOGIES, INC. 6575 WEST LOOP SOUTH, SUITE 200 BELLAIRE, TX 77401 US Other 510(k) Applications for this Company
Contact	Zaffer Syed Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2015
Decision Date	07/08/2016
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