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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 K233857
Device Name Neodent Implant System – Custom Abutments
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
Av. Juscelino Kubitschek De Oliveira, 3291 – Cic
Curitiba,  BR 81270-200
Applicant Contact Leticia Milani
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/05/2023
Decision Date 05/02/2024
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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