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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 K081396
Device Name SWISSPLANT DENTAL IMPLANT SYSTEM
Applicant
IMPLANT DIRECT LLC
27030 MALIBU HILLS RD.
CALABASAS HILLS,  CA  91301
Applicant Contact THOMAS GOTTENBOS
Correspondent
IMPLANT DIRECT LLC
27030 MALIBU HILLS RD.
CALABASAS HILLS,  CA  91301
Correspondent Contact THOMAS GOTTENBOS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/19/2008
Decision Date 01/14/2009
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
Recalls CDRH Recalls
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