FDA.reportPublic FDA data

510(k) K251129

Device
S.I.N. Tapered Pro Conical Zygoma Implant System
Applicant
S.I.N. Implant System Ltda
510(k) number
K251129
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-07
Date received
2025-04-11
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
Denise Domiciano
Address
Rua Soldado Ocimar Guimarães Da Silva, 421 São Paulo BR 03348-060 03348-060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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