510(k) K962680

HYUNJAE DENTAL IMPRESSION MATERIALS by Hyunjae Corp. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1996
Date Received
July 10, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type