510(k) K972971

NPG + 2 by Aalba Dent, Inc. — Product Code EJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1998
Date Received
August 11, 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