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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adhesive, Bracket And Tooth Conditioner, Resin
510(k) Number K001446
Device Name LIGHT-CURED ORTHODONTIC BAND CEMENT
Applicant
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768
Applicant Contact JAN A ORLOWSKI
Correspondent
Scientific Pharmaceuticals, Inc.
3221 Producer Way
Pomona,  CA  91768
Correspondent Contact JAN A ORLOWSKI
Regulation Number872.3750
Classification Product Code
DYH  
Date Received05/08/2000
Decision Date 07/21/2000
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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