FDA 510(k) Application Details - K050730

Device Classification Name	Bracket, Plastic, Orthodontic   More FDA Info for this Device
510(K) Number	K050730
Device Name	Bracket, Plastic, Orthodontic
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	TAMMY LAVERY 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	03/21/2005
Decision Date	03/31/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review