Cleared Traditional

CLEARTEMP

K111017 · Ultradent Products, Inc. · Dental
Jun 2011
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K111017 is an FDA 510(k) clearance for the CLEARTEMP, 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 June 6, 2011, 55 days after receiving the submission on April 12, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K111017 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2011
Decision Date June 06, 2011
Days to Decision 55 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