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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
60 Minuteman Road
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
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