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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 K202282
Device Name Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Materiais Dentarios SA
Av. Juscelino Kubitschek de Oliveira, 3291 – CIC
Curitiba,  BR 81270-200
Applicant Contact Mariana Soares Hartmann
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
Date Received08/12/2020
Decision Date 01/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No