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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 K942767
Device Name ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN
Applicant
Wallace A. Erickson & Co.
1920 N. Clybourn Ave.
Chicago,  IL  60614
Applicant Contact GEORGE NICOLAE
Correspondent
Wallace A. Erickson & Co.
1920 N. Clybourn Ave.
Chicago,  IL  60614
Correspondent Contact GEORGE NICOLAE
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/13/1994
Decision Date 07/08/1994
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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