Cleared Traditional

MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH

K120404 · Merz Dental GmbH · Dental
May 2012
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K120404 is an FDA 510(k) clearance for the MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on May 21, 2012, 102 days after receiving the submission on February 9, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K120404 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2012
Decision Date May 21, 2012
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code ELM — Denture, Plastic, Teeth
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3590