510(k) K032106

STARBOND DENTAL BONDING ALLOYS by Star Refining Precious Metals South Africa — Product Code EJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2003
Date Received
July 8, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type