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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
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
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
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
Predetermined Change
Control Plan Authorized		 No
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