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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 K001108
Device Name PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL
Applicant
Prime Dental Manufacturing, Inc.
3735 W. Belmont Ave.
Chicago,  IL  60618
Applicant Contact ROLANDDO MARASIGAN
Correspondent
Prime Dental Manufacturing, Inc.
3735 W. Belmont Ave.
Chicago,  IL  60618
Correspondent Contact ROLANDDO MARASIGAN
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/05/2000
Decision Date 05/30/2000
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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