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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 K110642
Device Name SILJETR SYSTEM
Applicant
Danville Materials, Inc.
3420 Fostoria Way St. A-200
San Ramon,  CA  94583
Applicant Contact LINDSAY TILTON
Correspondent
Danville Materials, Inc.
3420 Fostoria Way St. A-200
San Ramon,  CA  94583
Correspondent Contact LINDSAY TILTON
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
KLE   KOJ  
Date Received03/07/2011
Decision Date 05/27/2011
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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