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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 K994224
Device Name PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL
Applicant
Prime Dental Manufacturing, Inc.
3735 W. Belmont Ave.
Chicago,  IL  60618
Applicant Contact ROLANDO MARASIGAN
Correspondent
Prime Dental Manufacturing, Inc.
3735 W. Belmont Ave.
Chicago,  IL  60618
Correspondent Contact ROLANDO MARASIGAN
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
KLE  
Date Received12/15/1999
Decision Date 01/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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