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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K984503
Device Name ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000
Applicant
WALLACE A. ERICKSON & CO.
1920 NORTH CLYBOURN AVE.
CHICAGO,  IL  60614
Applicant Contact ABNER T DE LA CRUZ
Correspondent
WALLACE A. ERICKSON & CO.
1920 NORTH CLYBOURN AVE.
CHICAGO,  IL  60614
Correspondent Contact ABNER T DE LA CRUZ
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/18/1998
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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