Manufacturer registered with FDA
S.i.n. - Sistema de Implante Nacional S.A.
Sao Paulo, Brazil. Lists 4 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 42025–2025
- Markets registered in
- 7466 registrations outside the US
- Establishments
- 1Brazil
510(k) clearances per year, 2007–2026
Registered in 7 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 | Manufacturer | S.i.n. - Sistema de Implante Nacional S.A. | 4 clearances | 2025–2025 | Below |
| Canada | Health Canada | Registration holder | S.I.N. IMPLANT SYSTEM LTDA | 192 | 2025–2026 | Pure Global AI |
| Brazil | ANVISA | Registration holder | S.I.N. IMPLANT SYSTEM LTDA | 155 | 2005–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | S.I.N. Implant System Ltda. | 63 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | S.I.N. IMPLANT SYSTEM LTDAS.I.N implant System LTDA | 32 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | S.I.N. IMPLANT SYSTEM LTDA.SIN SISTEMA DE IMPLANTE NACIONAL S.A | 15 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | S.I.N. IMPLANT SYSTEM LTDA | 9 | 2022–2026 | 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
Devices listed with FDA
What S.i.n. - Sistema de Implante Nacional S.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | S.I.N. Dental Implant SystemSistema de Implante Nacional (S. I. N.) Dental Implant System | 2004 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | S.I.N. Dental Implant SystemSistema de Implante Nacional (S. I. N.) Dental Implant System | 2004 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor | 2020 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | BioHorizonsSistema de Implante Nacional (S. I. N.) Dental Implant Accessories | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names S.i.n. - Sistema de Implante Nacional S.A. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Nov 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | DZE Root-Form Endosseous Implant |
| 17 Oct 2025 | K252266 | S.I.N. Dental Implant System | NHA Endosseous Dental Implant Abutment |
| 26 Sep 2025 | K251262 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
| 13 Aug 2025 | K251046 | S.I.N. Dental Implant System | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
S.i.n. - Sistema de Implante Nacional S.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: S.I.N. - Sistema DE Implante Nacional S.A. (13).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Jul 2024 | K240609 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 31 May 2024 | K232821 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 7 Dec 2023 | K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 6 Apr 2023 | K230069 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | NHA Endosseous Dental Implant Abutment |
| 15 Dec 2022 | K221453 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 27 Oct 2022 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 20 Oct 2021 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 23 Jun 2021 | K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 17 Nov 2020 | K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 14 May 2020 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 1 Dec 2017 | K170392 | S.I.N. Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 21 Nov 2017 | K170398 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 23 Sep 2005 | K051859 | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM | S.I.N. - Sistema DE Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| S.I.N. Implant System LtdaFDA reg. 3004201263 | SAO PAULO, Brazil | Contract manufacturer, Manufacturer |
Other names on FDA records
Sin Sistema de Implante Nacional S.A. · S.i.n. Implant System Ltda
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059509). 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.