FDA 510(k) Application Details - K110796

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K110796
Device Name	Bracket, Plastic, Orthodontic
Applicant	BIOMERS PRODUCTS, LLC 1275 WEST 6TH AVENUE SUITE 399 VANCOUVER, BC V6H 1A6 CA Other 510(k) Applications for this Company
Contact	DARYL WISDAHL 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	03/22/2011
Decision Date	03/31/2011
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