FDA 510(k) Application Details - K101481

Device Classification Name	Bracket, Ceramic, Orthodontic   More FDA Info for this Device
510(K) Number	K101481
Device Name	Bracket, Ceramic, Orthodontic
Applicant	BIOMERS PRODUCTS, LLC 18912 NORTH CREEK PARKWAY SUITE 210 BOTHELL, WA 98011 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	NJM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2010
Decision Date	06/23/2010
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