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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K043054
Device Name GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
Applicant
Sultan Chemists, Inc.
85 W. Forest Ave.
Englewood,  NJ  07631
Applicant Contact CLARK SMITH
Correspondent
Sultan Chemists, Inc.
85 W. Forest Ave.
Englewood,  NJ  07631
Correspondent Contact CLARK SMITH
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/05/2004
Decision Date 02/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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