FDA 510(k) Application Details - K123094

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K123094
Device Name	Bracket, Ceramic, Orthodontic
Applicant	TOMY, INC. 7046 OWL'S NEST TERRACE BRADENTON, FL 34203 US Other 510(k) Applications for this Company
Contact	CAROLYN PRIMUS 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	10/02/2012
Decision Date	12/13/2012
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