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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 K191191
Device Name Neodent Implant System - Temporary Abutments
Applicant
JJGC Industria e Comercio de Materiais Dentarios S.A.
Av. Juscelino Kubitschek de Oliveira, 3291 - CIC
curitiba,  BR 81270-200
Applicant Contact mariana soares hartmann
Correspondent
Straumann USA, LLC
60 Minuteman Road
andover,  MA  01810
Correspondent Contact jennifer m. jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/03/2019
Decision Date 12/05/2019
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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