Cleared Traditional

K111958 - TETRIC EVOCERAM BULK FILL (FDA 510(k) Clearance)

K111958 · Ivoclar Vivadent, Inc. · Dental device

Oct 2011

Decision

95d

Days

Class 2

Risk

K111958 is an FDA 510(k) clearance for the TETRIC EVOCERAM BULK FILL. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K111958 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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