Cleared Traditional

RD-3008

K011036 · Heraeus Kulzer, Inc. · Dental
May 2001
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K011036 is an FDA 510(k) clearance for the RD-3008, a Alloy, Gold-based Noble Metal (Class II — Special Controls, product code EJT), submitted by Heraeus Kulzer, Inc. (Armonk, US). The FDA issued a Cleared decision on May 10, 2001, 35 days after receiving the submission on April 5, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K011036 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2001
Decision Date May 10, 2001
Days to Decision 35 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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