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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 K100653
Device Name JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD
Applicant
Lang Dental Mfg. Co., Inc.
175 Messner Dr.
Wheeling,  IL  60090
Applicant Contact DAVID LANG
Correspondent
Lang Dental Mfg. Co., Inc.
175 Messner Dr.
Wheeling,  IL  60090
Correspondent Contact DAVID LANG
Regulation Number872.3760
Classification Product Code
EBI  
Date Received03/08/2010
Decision Date 10/08/2010
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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