510(k) K902350

PALATRAY LC RESIN IMPRESSION TRAY MATERIAL by Kulzer, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1990
Date Received
May 25, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression Tray, Resin
Device Class
Class I
Regulation Number
872.3670
Review Panel
DE
Submission Type