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510(k) K221453

Device
S.I.N. Dental Implant System
Applicant
S.I.N. ? Sistema DE Implante Nacional S.A.
510(k) number
K221453
Product code
DZE
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-15
Date received
2022-05-19
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
Avenida Vereador Abel Ferreira, 1100 São Paulo BR 03340-000 03340-000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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