FDA.report

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

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
07899995201065ABUTMENT CHROME COBALT MULTIFUNCTIONALSin Sistema de Implante Nacional S/A2023-07-11
07899995279118TEMPORARY CYLINDER INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995274403INTERFACE CHROME COBALT 4MM INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995255716INTERFACE CHROME COBALT 6MM INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995252869ABUTMENT CHROME COBALT MICRO MINI INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995201317INTERFACE CHROME COBALT MULTI INDEX 6MMSin Sistema de Implante Nacional S/A2023-07-11
07899995201300INTERFACE CHROME COBALT MULTI 4.0MMSin Sistema de Implante Nacional S/A2023-07-11
07899995201287INTERFACE CHROME COBALT MULTI 6.0MMSin Sistema de Implante Nacional S/A2023-07-11
07899995201140TEMPORARY CYLINDER ABUT MULTI INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995201096TEMPORARY CYLINDER ABUT MULTIFUNCTIONALSin Sistema de Implante Nacional S/A2023-07-11
07899995201072ABUTMENT CHROME COBALT MULTI INDEXSin Sistema de Implante Nacional S/A2023-07-11
07899995278968IMPLANT EPIKUT CM PLUS Ø4,5 X 18,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278111IMPLANT EPIKUT CM PLUS Ø3,8 X 22,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278128IMPLANT EPIKUT CM PLUS Ø3,8 X 20,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278135IMPLANT EPIKUT CM PLUS Ø3,8 X 18,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278906IMPLANT EPIKUT CM PLUS Ø4,5 X 24,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278913IMPLANT EPIKUT CM PLUS Ø4,5 X 22,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278937IMPLANT EPIKUT CM PLUS Ø4,5 X 20,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995278975IMPLANT EPIKUT CM PLUS Ø3,8 X 24,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995279415IMPLANT EPIKUT CM PLUS Ø4,0 X 24,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995279439IMPLANT EPIKUT CM PLUS Ø4,0 X 22,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995279453IMPLANT EPIKUT CM PLUS Ø4,0 X 20,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995279460IMPLANT EPIKUT CM PLUS Ø4,0 X 18,0MMSin Sistema de Implante Nacional S/A2023-06-21
07899995279552IMPLANT EPIKUT CM Ø4,0 X 20,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995279606IMPLANT EPIKUT CM Ø4,0 X 18,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995279538IMPLANT EPIKUT CM Ø4,0 X 24,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995279514IMPLANT EPIKUT CM Ø4,0 X 22,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995278265IMPLANT EPIKUT CM Ø3,8 X 18,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995278258IMPLANT EPIKUT CM Ø3,8 X 20,0MMSin Sistema de Implante Nacional S/A2023-06-14
07899995278241IMPLANT EPIKUT CM Ø3,8 X 22,0MMSin Sistema de Implante Nacional S/A2023-06-14

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