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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K925162
Device Name MICRODOSE DENTIN CONDITIONER
Applicant
Unicep
P.O. Box 1827
804 Airport Way
Sandpoint,  ID  83864
Applicant Contact JOHN SNEDDEN
Correspondent
Unicep
P.O. Box 1827
804 Airport Way
Sandpoint,  ID  83864
Correspondent Contact JOHN SNEDDEN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/13/1992
Decision Date 03/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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