Cleared Special

Astringedent Clear

K152064 · Ultradent Products, Inc. · Dental
Sep 2015
Decision
62d
Days
—
Risk

About This 510(k) Submission

K152064 is an FDA 510(k) clearance for the Astringedent Clear, a Cord, Retraction, submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 24, 2015, 62 days after receiving the submission on July 24, 2015. This device falls under the Dental review panel.

Submission Details

510(k) Number K152064 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2015
Decision Date September 24, 2015
Days to Decision 62 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL — Cord, Retraction
Device Class —