FDA.report

510(k) K252090

Device
Pterygoid Indication for GM Helix Implants
Applicant
JJGC Indústria e Comércio de Materiais Dentários S.A.
510(k) number
K252090
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-12
Date received
2025-07-02
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
N

Related Records

Applicant Contact

Contact
Mariana Hartmann
Address
Av. Juscelino Kubitschek De Oliveira, 3291 Curitiba BR 81270-200 81270-200

FDA Registration Numbers

Source Documents

510(k) summary PDF

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