Cleared Traditional

TETRIC EVOCERAM BULK FILL

K111958 · Ivoclar Vivadent, Inc. · Dental
Oct 2011
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K111958 is an FDA 510(k) clearance for the TETRIC EVOCERAM BULK FILL, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on October 14, 2011, 95 days after receiving the submission on July 11, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K111958 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2011
Decision Date October 14, 2011
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690