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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 K033773
Device Name CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
Applicant
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact DONNA MARIE HARTNETT
Correspondent
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact DONNA MARIE HARTNETT
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/03/2003
Decision Date 01/15/2004
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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