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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 K960165
Device Name ALPHA-DENT COMPOSITE SURFACE SEALANT
Original Applicant
WALLACE A. ERICKSON & CO.
1920 north clybourn ave.
chicago,  IL  60614
Original Contact abner t de la cruz
Regulation Number872.3690
Classification Product Code
EBF  
Date Received01/16/1996
Decision Date 03/15/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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