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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 K140070
Device Name LUXER SHADED ZIRCONIA
Applicant
Continental Dental Ceramics, Inc.
1872 Western Way
Torrance,  CA  90501
Applicant Contact JERRY DOVIACK
Correspondent
Continental Dental Ceramics, Inc.
1872 Western Way
Torrance,  CA  90501
Correspondent Contact JERRY DOVIACK
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/13/2014
Decision Date 05/07/2014
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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