510(k) K902115

PALAPRESS(R) VARIO RESIN by Kulzer, Inc. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1990
Date Received
May 10, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type