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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 K133071
Device Name ELASTIC IMPRESSION MATERIAL
Applicant
Rizhao Huge Dental Industry Co., Ltd.
3500 S. Dupont Highway
Dover,  DE  19901
Applicant Contact LEON LU
Correspondent
Rizhao Huge Dental Industry Co., Ltd.
3500 S. Dupont Highway
Dover,  DE  19901
Correspondent Contact LEON LU
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/30/2013
Decision Date 05/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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