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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 K100781
Device Name OBSIDIAN CERAMIC BLOCKS
Applicant
Prismatik Dentalcraft, Inc.
4141 Macarthur Blvd.
Newport Beach,  CA  92660
Applicant Contact KEITH ALLRED
Correspondent
Prismatik Dentalcraft, Inc.
4141 Macarthur Blvd.
Newport Beach,  CA  92660
Correspondent Contact KEITH ALLRED
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/19/2010
Decision Date 06/21/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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