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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K092319
Device Name STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387
Applicant
Danville Materials, Inc.
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Applicant Contact CRAIG BRUNS
Correspondent
Danville Materials, Inc.
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Correspondent Contact CRAIG BRUNS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received08/04/2009
Decision Date 09/16/2009
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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