510(k) K972118

VERA PDN by Aalba Dent, Inc. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1997
Date Received
June 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type