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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 K062695
Device Name SAGEMAX Z-BLANK
Applicant
Sagemax Bioceramics, Inc.
11061 NE 2nd St.
Suite 168
Bellevue,  WA  98004
Applicant Contact LARRY DANG
Correspondent
Sagemax Bioceramics, Inc.
11061 NE 2nd St.
Suite 168
Bellevue,  WA  98004
Correspondent Contact LARRY DANG
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/11/2006
Decision Date 10/20/2006
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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