Cleared Traditional

M-PM-DISC

K134015 · Merz Dental GmbH · Dental
Apr 2014
Decision
105d
Days
—
Risk

About This 510(k) Submission

K134015 is an FDA 510(k) clearance for the M-PM-DISC, a Mouthguard, Prescription, submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on April 11, 2014, 105 days after receiving the submission on December 27, 2013. This device falls under the Dental review panel.

Submission Details

510(k) Number K134015 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2013
Decision Date April 11, 2014
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —