510(k) K082800

STAR/VENT INTERNAL HEX SCREW IMPLANT by Park Dental Research Corp. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2010
Date Received
September 24, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type