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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 K090234
Device Name SPECTRA SYSTEM DENTAL IMPLANTS 2008
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 Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/30/2009
Decision Date 05/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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