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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K052823
Device Name IMPLANTIUM ABUTMENTS
Applicant
Dentium, Inc.
28711 Jaeger Dr.
Laguna Niguel,  CA  92677
Applicant Contact KLAAS BESSELING
Correspondent
Dentium, Inc.
28711 Jaeger Dr.
Laguna Niguel,  CA  92677
Correspondent Contact KLAAS BESSELING
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/04/2005
Decision Date 02/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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