Cleared Traditional

K111017 - CLEARTEMP (FDA 510(k) Clearance)

K111017 · Ultradent Products, Inc. · Dental device

Jun 2011

Decision

55d

Days

Class 2

Risk

K111017 is an FDA 510(k) clearance for the CLEARTEMP. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K111017 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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