510(k) K852182

EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER by The S. S. White Co. — Product Code EBH

K852182 is an FDA 510(k) premarket notification submitted by The S. S. White Co. for the device "EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER". The FDA issued a decision of Substantially Equivalent on July 2, 1985. The device falls under product code EBH (Material, Impression Tray, Resin), a Class I device regulated under 21 CFR 872.3670. The S. S. White Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
May 20, 1985
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