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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
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