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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 K122972
Device Name CDC ZIRCONIA BLANKS
Applicant
Continental Dental Ceramics, Inc. (Dba Continental
1873 Western Way
Torrance,  CA  90501
Applicant Contact JERRY DOVIACK, CDT
Correspondent
Continental Dental Ceramics, Inc. (Dba Continental
1873 Western Way
Torrance,  CA  90501
Correspondent Contact JERRY DOVIACK, CDT
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/26/2012
Decision Date 10/24/2012
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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