FDA 510(k) Application Details - K112707

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K112707
Device Name	Bracket, Ceramic, Orthodontic
Applicant	ORTHO TECHNOLOGY, INC 17401 COMMERCE PARK BLVD. TAMPA, FL 33647 US Other 510(k) Applications for this Company
Contact	JODI HUTCHINS 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	09/19/2011
Decision Date	01/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review