Cleared Traditional

GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL

K043054 · Sultan Chemists, Inc. · Dental
Feb 2005
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K043054 is an FDA 510(k) clearance for the GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Sultan Chemists, Inc. (Englewood, US). The FDA issued a Cleared decision on February 18, 2005, 105 days after receiving the submission on November 5, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K043054 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2004
Decision Date February 18, 2005
Days to Decision 105 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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