510(k) K801780

OXY CUSTOM TRAY RESIN by Oxy Dental Products, Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1980
Date Received
July 28, 1980
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