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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 K863031
Device Name TWIN-CORE
Applicant
Scientific Pharmaceuticals, Inc.
1828 Evergreen St.
Duarte,  CA  91010
Applicant Contact JAN A ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
1828 Evergreen St.
Duarte,  CA  91010
Correspondent Contact JAN A ORLOWSKI
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/11/1986
Decision Date 09/22/1986
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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