510(k) K820028

ZEON COMPOSITE RESIN LIGHT CURE SYS by National Patent Development Corp. — Product Code EBF

K820028 is an FDA 510(k) premarket notification submitted by National Patent Development Corp. for the device "ZEON COMPOSITE RESIN LIGHT CURE SYS". The FDA issued a decision of Substantially Equivalent on March 11, 1982. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. National Patent Development Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
January 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type