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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 K130991
Device Name NEXXZR(TM)T AND NEXXZR(TM)S
Applicant
Sagemax Bioceramics, Inc.
34210 9th Ave. S., Suite 118
Federal Way,  WA  98003
Applicant Contact JOSE E CABRERA
Correspondent
Sagemax Bioceramics, Inc.
34210 9th Ave. S., Suite 118
Federal Way,  WA  98003
Correspondent Contact JOSE E CABRERA
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/10/2013
Decision Date 02/10/2014
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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