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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K130604
Device Name UNIVERSAL PASTE STAINS AND GLAZE
Applicant
Prismatik Dentalcraft, Inc.
2212 Dupont Dr.,
Suite Jjk
Irvine,  CA  92612
Applicant Contact ARMIN ZEHTABCHI
Correspondent
Prismatik Dentalcraft, Inc.
2212 Dupont Dr.,
Suite Jjk
Irvine,  CA  92612
Correspondent Contact ARMIN ZEHTABCHI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/07/2013
Decision Date 09/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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