FDA 510(k) Application Details - K954030

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K954030
Device Name	Implant, Endosseous, Root-Form
Applicant	LEIBINGER GMBH 14540 BELTWOOD PARKWAY EAST DALLAS, TX 75244 US Other 510(k) Applications for this Company
Contact	ANDREW B ROGERS 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	08/28/1995
Decision Date	11/14/1997
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