Cleared Traditional

VISCOSTAT CLEAR

K123215 · Ultradent Products, Inc. · Dental

Feb 2013

Decision

113d

Days

—

Risk

About This 510(k) Submission

K123215 is an FDA 510(k) clearance for the VISCOSTAT CLEAR, a Cord, Retraction, submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 5, 2013, 113 days after receiving the submission on October 15, 2012. This device falls under the Dental review panel.

Submission Details

510(k) Number	K123215 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2012
Decision Date	February 05, 2013
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF