FDA 510(k) Application Details - K110661

Device Classification Name	More FDA Info for this Device
510(K) Number	K110661
Device Name	ACCELEDENT
Applicant	ORTHOACCEL TECHNOLOGIES, INC 8275 EL RIO, SUITE 100 HOUSTON, TX 77054 US Other 510(k) Applications for this Company
Contact	MICHAEL E KAUFMAN 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	03/08/2011
Decision Date	11/17/2011
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