Cleared Traditional

PREMIUM

K011130 · Heraeus Kulzer, Inc. · Dental
Jul 2001
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K011130 is an FDA 510(k) clearance for the PREMIUM, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Heraeus Kulzer, Inc. (Armonk, US). The FDA issued a Cleared decision on July 5, 2001, 83 days after receiving the submission on April 13, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number K011130 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2001
Decision Date July 05, 2001
Days to Decision 83 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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

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