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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 K193592
Device Name Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
Applicant
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Av. Juscelino Kubitschek De Oliveira, 3291- Cic
Curitiba,  BR 8127 0-200
Applicant Contact Mariana Soares Hartmann
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/23/2019
Decision Date 04/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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