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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 K060063
Device Name LEGACY ABUTMENT SYSTEM
Applicant
IMPLANT DIRECT LLC
27030 MALIBU HILLS RD.
CALABASAS HILLS,  CA  91301
Applicant Contact ROSEMARIE MASTELLER
Correspondent
IMPLANT DIRECT LLC
27030 MALIBU HILLS RD.
CALABASAS HILLS,  CA  91301
Correspondent Contact ROSEMARIE MASTELLER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/09/2006
Decision Date 05/19/2006
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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