Cleared Traditional

PERMASHADE VENEER CEMENT

K111836 · Ultradent Products, Inc. · Dental
Sep 2011
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K111836 is an FDA 510(k) clearance for the PERMASHADE VENEER CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 16, 2011, 79 days after receiving the submission on June 29, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K111836 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2011
Decision Date September 16, 2011
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275