Cleared Traditional

NDX-40 ALLOY

K040043 · Heraeus Kulzer, Inc. · Dental
Mar 2004
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K040043 is an FDA 510(k) clearance for the NDX-40 ALLOY, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on March 3, 2004, 51 days after receiving the submission on January 12, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K040043 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2004
Decision Date March 03, 2004
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJT — Alloy, Gold-based Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060

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