FDA 510(k) Application Details - K170093

Device Classification Name	More FDA Info for this Device
510(K) Number	K170093
Device Name	AcceleDent Optima
Applicant	OrthoAccel Technology Inc. 6575 West Loop South, Suite 200 Bellaire, TX 77401 US Other 510(k) Applications for this Company
Contact	Jouana Harris-Livings 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	01/11/2017
Decision Date	05/26/2017
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