FDA 510(k) Application Details - K112875

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K112875
Device Name	Implant, Endosseous, Root-Form
Applicant	BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 GRAYSLAKE, IL 60030 US Other 510(k) Applications for this Company
Contact	MICHELE VOVOLKA Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2011
Decision Date	01/27/2012
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