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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, root-form
510(k) Number K093595
Device Name CERAROOT IMPLANT SYSTEM
Applicant
ORAL ICEBERG S.L.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact STUART R GOLDMAN
Correspondent
ORAL ICEBERG S.L.
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact STUART R GOLDMAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/19/2009
Decision Date 01/04/2011
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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