510(k) K831293

SOLARCRYL CUSTOM TRAY MATERIAL by Solar Dental Co., Inc. — Product Code EBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1983
Date Received
April 20, 1983
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