FDA.report

510(k) K230069

Device
S.I.N. Dental Implant System
Applicant
S.I.N. – Sistema DE Implante Nacional S.A.
510(k) number
K230069
Product code
NHA
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-06
Date received
2023-01-10
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
N

Related Records

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

Related GUDID Devices

Primary DIBrandCompanyPublished
07899995299895ABUT. PRE MILLED Ø12MM MT16° AGSin Sistema de Implante Nacional S/A2023-07-11
07899995280916ABUT. PRE MILLED Ø11,5MM MT16° MKSin Sistema de Implante Nacional S/A2023-07-11
07899995273192ABUT. PRE MILLED Ø15,8MM MT16° MKSin Sistema de Implante Nacional S/A2023-07-11
07899995273123ABUT. PRE MILLED Ø10MM MT16° DSSin Sistema de Implante Nacional S/A2023-07-11
07899995273109ABUT. PRE MILLED Ø14MM MT16° DSSin Sistema de Implante Nacional S/A2023-07-11
07899995273079ABUT. PRE MILLED Ø12MM CM11,5° AGSin Sistema de Implante Nacional S/A2023-07-11
07899995273062ABUT. PRE MILLED Ø11,5MM CM11,5°MKSin Sistema de Implante Nacional S/A2023-07-11
07899995273048ABUT. PRE MILLED Ø15,8MM CM11,5° MKSin Sistema de Implante Nacional S/A2023-07-11
07899995272935ABUT. PRE MILLED Ø10MM CM11,5° DSSin Sistema de Implante Nacional S/A2023-07-11
07899995272829ABUT. PRE MILLED Ø14MM CM11,5° DSSin Sistema de Implante Nacional S/A2023-07-11

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