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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 K152349
Device Name Star+ VPS Scannable Impression Material
Applicant
Danville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Applicant Contact DONG HUA
Correspondent
Danville Materials, LLC
3420 Fostoria Way Suite A-200
San Ramon,  CA  94583
Correspondent Contact DONG HUA
Regulation Number872.3660
Classification Product Code
ELW  
Date Received08/20/2015
Decision Date 11/23/2015
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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