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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 K904812
Device Name COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE
Applicant
Alpha-Dent
1920 N. Clybourn Ave.
Chicago,  IL  60614
Applicant Contact GEIRGE NICOLAE
Correspondent
Alpha-Dent
1920 N. Clybourn Ave.
Chicago,  IL  60614
Correspondent Contact GEIRGE NICOLAE
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/25/1990
Decision Date 02/26/1991
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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