510(k) K912820

POLYESTER RESIN HAND MOLDED TRAY by E&D Dental Products, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1991
Date Received
June 25, 1991
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