510(k) K961434

VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM by Vident — Product Code EBF

K961434 is an FDA 510(k) premarket notification submitted by Vident for the device "VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 8, 1996. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Vident has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1996
Date Received
April 15, 1996
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