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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K040952
Device Name PRELUDE
Applicant
Danville Materials, Inc.
2021 Omega Dr.
San Ramon,  CA  94583
Applicant Contact CRAIG BURNS
Correspondent
Danville Materials, Inc.
2021 Omega Dr.
San Ramon,  CA  94583
Correspondent Contact CRAIG BURNS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received04/12/2004
Decision Date 06/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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