FDA 510(k) Application Details - K061323

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K061323
Device Name	Implant, Endosseous, Root-Form
Applicant	BIOINFERA, INC. 23230 CHAGRIN BLVD. SUITE # 950 BEACHWOOD, OH 44122 US Other 510(k) Applications for this Company
Contact	CHAN Q WANG 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	05/11/2006
Decision Date	05/23/2007
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