Cleared Traditional

PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS

K130076 · Merz Dental GmbH · Dental
Aug 2013
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K130076 is an FDA 510(k) clearance for the PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS, 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 August 22, 2013, 220 days after receiving the submission on January 14, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K130076 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2013
Decision Date August 22, 2013
Days to Decision 220 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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