FDA 510(k) Application Details - K140807

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K140807
Device Name	Bracket, Plastic, Orthodontic
Applicant	ORTHO SPECIALTIES 207 PHEASANT MEADOW CT. GURNEE, IL 60031 US Other 510(k) Applications for this Company
Contact	PAULA WENDLAND Other 510(k) Applications for this Contact
Regulation Number	872.5470   More FDA Info for this Regulation Number
Classification Product Code	DYW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2014
Decision Date	11/12/2014
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