FDA 510(k) Application Details - K081143

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K081143
Device Name	Bracket, Plastic, Orthodontic
Applicant	BIOMERS PRODUCT, LLC 2316 PINE RIDGE ROAD SUITE 459 NAPLES, FL 34109 US Other 510(k) Applications for this Company
Contact	GEORGE ALIPHTIRAS 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	04/22/2008
Decision Date	05/02/2008
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	Y
Expedited Review