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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K152981
Device Name JET SET 4 DENTURE REPAIR RESIN
Applicant
Lang Dental Manufacturing Company, Inc.
175 Messner Dr.
Wheeling,  IL  60090
Applicant Contact DAVID LANG
Correspondent
Lang Dental Manufacturing Company, Inc.
175 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact DAVID LANG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/09/2015
Decision Date 09/02/2016
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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