FDA 510(k) Application Details - K062305

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K062305
Device Name	Bracket, Ceramic, Orthodontic
Applicant	3M UNITEK 2724 SOUTH PECK RD. MONROVIA, CA 91016 US Other 510(k) Applications for this Company
Contact	L MARLYN SCHEFF 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	08/08/2006
Decision Date	10/18/2006
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