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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 K111709
Device Name FOUNDATION DENTAL RESIN
Applicant
Unix-Japan Co., Ltd.
10920 Wilshire Blvd.
Suite 150
Los Angeles,  CA  90024
Applicant Contact TOSHIKO BOYD
Correspondent
Unix-Japan Co., Ltd.
10920 Wilshire Blvd.
Suite 150
Los Angeles,  CA  90024
Correspondent Contact TOSHIKO BOYD
Regulation Number872.3760
Classification Product Code
EBI  
Date Received06/20/2011
Decision Date 11/18/2011
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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