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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 K083543
Device Name DENOVISMED DENTAL IMPLANT SYSTEMS
Applicant
DENOVIS MEDICAL, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact kevin a thomas
Correspondent
DENOVIS MEDICAL, LLC
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/28/2008
Decision Date 03/06/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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