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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coating, Filling Material, Resin
510(k) Number K850675
Device Name CURAY JOIN DENT DENTIN PRIMER
Applicant
Scientific Pharmaceuticals, Inc.
1828 Evergreen St.
Duarte,  CA  91010
Applicant Contact JAN ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
1828 Evergreen St.
Duarte,  CA  91010
Correspondent Contact JAN ORLOWSKI
Regulation Number872.3310
Classification Product Code
EBD  
Date Received02/21/1985
Decision Date 03/25/1985
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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