Not currently registered with FDA under this name
S.I.N. - Sistema DE Implante Nacional S.A.
São Paulo, Brazil. Named as applicant on 13 dental 510(k) clearances between 2005 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 132005–2024
- Markets registered in
- 5149 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name S.I.N. - Sistema DE Implante Nacional S.A. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | S.I.N. - Sistema DE Implante Nacional S.A. | 13 clearances | 2005–2024 | Below |
| Colombia | INVIMA | Registration holder | SIN SISTEMA DE IMPLANTE NACIONAL S.A.SIN SISTEMA DE IMPLANTE NACIONAL LTDA | 115 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SIN - SISTEMA DE IMPLANTE NACIONAL S.A.SIN SISTEMA DE IMPLANTE NACIONAL LTDA | 13 | 2010–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SIN-SISTEMA DE IMPLANTE NACIONAL S.A. | 12 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SIN - SISTEMA DE IMPLANTE NACIONAL S.A.SIN-SISTEMA DE IMPLANTE NACIONAL S.A. | 9 | 2018–2023 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names S.I.N. - Sistema DE Implante Nacional S.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Jul 2024 | K240609 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 31 May 2024 | K232821 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 7 Dec 2023 | K231127 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 6 Apr 2023 | K230069 | S.I.N. Dental Implant System | NHA Endosseous Dental Implant Abutment |
| 15 Dec 2022 | K221453 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 27 Oct 2022 | K222231 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 20 Oct 2021 | K211921 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 23 Jun 2021 | K203725 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 17 Nov 2020 | K200992 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 14 May 2020 | K193096 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 1 Dec 2017 | K170392 | S.I.N. Implant System | DZE Root-Form Endosseous Implant |
| 21 Nov 2017 | K170398 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 23 Sep 2005 | K051859 | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: S.i.n. - Sistema de Implante Nacional S.A. (13).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.