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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 K133510
Device Name NEODENT IMPLANT SYSTEM
Applicant
JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
11264 EL CAMINO REAL, SUITE 400
san diego,  CA  92130
Applicant Contact kevin a thomas
Correspondent
JJ INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS SA
11264 EL CAMINO REAL, SUITE 400
san diego,  CA  92130
Correspondent Contact kevin a thomas
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received11/14/2013
Decision Date 02/24/2014
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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