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510(k) K231803

Device
Neodent Implant System - Zirconia Implant System
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
510(k) number
K231803
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-13
Date received
2023-06-20
Regulation
872.3630
Classification name
Abutment, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mariana Soares Hartmann
Address
Av. Juscelino Kubitschek De Oliveira, 3291- Cic Curitiba BR 8127 0-200 8127 0-200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.2026-01-22
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K253341Custom Abutments ASMedentika GmbH2025-12-23
K253312OrangeCAD Med AbutmentsOrangecad Med GmbH2025-12-23
K252320SIMDA AbutmentsSimda Co., Ltd.2025-12-18