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510(k) K232099

Device
Neodent Implant System - GM Zygomatic Implant System
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
510(k) number
K232099
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-31
Date received
2023-07-13
Regulation
872.3640
Classification name
Implant, Endosseous, Root-Form
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 81270-200 81270-200

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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