Cleared Traditional

M-PM-DISC (PINK)

K140758 · Merz Dental GmbH · Dental
Sep 2014
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K140758 is an FDA 510(k) clearance for the M-PM-DISC (PINK), a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on September 15, 2014, 173 days after receiving the submission on March 26, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K140758 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2014
Decision Date September 15, 2014
Days to Decision 173 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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