Cleared Traditional

RETRACTION PASTE

K130580 · Dmg USA, Inc. · Dental

Feb 2014

Decision

357d

Days

—

Risk

About This 510(k) Submission

K130580 is an FDA 510(k) clearance for the RETRACTION PASTE, a Cord, Retraction, submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on February 25, 2014, 357 days after receiving the submission on March 5, 2013. This device falls under the Dental review panel.

Submission Details

510(k) Number	K130580 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 05, 2013
Decision Date	February 25, 2014
Days to Decision	357 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF