Data / Medical devices / Brazil / S.I.N. Implant System Ltda
S.I.N. Implant System Ltda: FDA-registered device maker in Sao Paulo, Brazil, 22 510(k) clearances
S.I.N. Implant System Ltda is registered with the FDA (registration 3004201263) in Sao Paulo, Brazil. It lists 5 device types. The FDA files 22 510(k) clearances under its listings, the newest dated November 7, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004201263
- Address
- Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco, Sao Paulo, Brazil, 03348-060
- Owner or operator
- S.I.N. - SISTEMA DE IMPLANTE NACIONAL S.A (9059509)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 25, 2004
- Registered through
- 2026
- Brand names listed
- BioHorizons, Cheek Retractor, S.I.N. Dental Implant System, S.I.N. Instrument Kit, S.I.N. Instrument Kits, Sistema de Implante Nacional (S. I. N.) Dental Implant Accessories, Sistema de Implante Nacional (S. I. N.) Dental Implant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | DZE | Substantially Equivalent | S.I.N. Implant System Ltda | accessdata.fda.gov |
| October 17, 2025 | K252266 | S.I.N. Dental Implant System | NHA | Substantially Equivalent | S.I.N. Implant System Ltda | accessdata.fda.gov |
| September 26, 2025 | K251262 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. Implant System Ltda | accessdata.fda.gov |
| August 13, 2025 | K251046 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. Implant System Ltda | accessdata.fda.gov |
| July 17, 2024 | K240609 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| July 12, 2024 | K241378 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| May 31, 2024 | K232821 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| December 7, 2023 | K231127 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| April 6, 2023 | K230069 | S.I.N. Dental Implant System | NHA | Substantially Equivalent | S.I.N. Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| December 15, 2022 | K221453 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| October 27, 2022 | K222514 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | S.I.N. Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| October 27, 2022 | K222231 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| September 29, 2022 | K222005 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| November 3, 2021 | K212404 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| October 20, 2021 | K211921 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| June 23, 2021 | K203725 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| November 17, 2020 | K200992 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| October 21, 2020 | K201688 | S.I.N. Instrument Kits | KCT | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| May 14, 2020 | K193096 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. - Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| December 1, 2017 | K170392 | S.I.N. Implant System | DZE | Substantially Equivalent | S.I.N. Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| November 21, 2017 | K170398 | S.I.N. Dental Implant System | DZE | Substantially Equivalent | S.I.N. Sistema DE Implante Nacional S.A. | accessdata.fda.gov |
| September 23, 2005 | K051859 | SISTEMA DE IMPLANTE NACIONAL (S.I.N.); DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Sin Sistema DE Implante Nacional Ltda | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 30, 2025 | 97553 | Class II | Ongoing | IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT | Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance. | accessdata.fda.gov |
| September 1, 2024 | 95983 | Class II | Ongoing | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N | Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Retractor, All Types
- All makers of Accessories, Implant, Dental, Endosseous
Updated November 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.