FDA 510(k) Application Details - K131197

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K131197
Device Name	Bracket, Ceramic, Orthodontic
Applicant	DENTAL MORELLI 18851 NE 29TH AVE 720 AVENTURA, FL 33180 US Other 510(k) Applications for this Company
Contact	TARA CONRAD Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2013
Decision Date	08/27/2013
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