# FDA device clearances in Brazil: 36 since Nov 2024

Updated October 22, 2026.

FDA made 36 device decisions for applicants in Brazil from November 21, 2024 to October 22, 2026: 36 510(k) clearances and De Novo grants and 0 PMA approvals and supplements, for 18 applicants. The newest, K262084 on October 22, 2026, is S.I.N. Instruments Kits from S.I.N. Implant System Ltda.

## The full list

FDA device clearances for applicants in Brazil: 36 rows for $5, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. Columns: Number, Pathway, Device name, Applicant, Applicant address, Contact, Decision, Decision date, Decision type, Date received, Product code, Device type, Device class, Panel, Applicant state, Applicant country, Supplement reason, Read on, Source. The new rows each week by email, about 1 row a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (contact, pathway, device name, applicant address, date received, device type and 5 more), which open on your screen as soon as the payment clears and come by email.

Buy: https://specstream.ai/data/fda-clearances/country/brazil

SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

- Decisions: 36
- 510(k) and De Novo: 36
- PMA: 0
- Latest decision: October 22, 2026

## Newest decisions

The newest 36 of 36, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

| Decision date | Number | Device | Applicant | Location | Decision | Type | Product code | Source |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| October 22, 2026 | K262084 | S.I.N. Instruments Kits | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | KCT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262084) |
| August 22, 2026 | K253910 | Stitch - Suture Wires and Tapes | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | GAT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253910) |
| August 19, 2026 | K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) special | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262537) |
| July 21, 2026 | K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261406) |
| July 1, 2026 | K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261147) |
| May 29, 2026 | K252396 | Cryo Sport 2.0 (AVA 501) | Avanutri Equipamentos DE Saúde | Brazil | Substantially Equivalent | 510(k) traditional | IRP | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252396) |
| May 6, 2026 | K253027 | Anchor with Fiber Wire and Disposable Inserter | Ortobio S.A. | Brazil | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253027) |
| April 23, 2026 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | EBF | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260152) |
| March 17, 2026 | K260390 | Super Upper Limbs Versalock Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260390) |
| February 19, 2026 | K254188 | Meniscus Versaflex | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | GAT | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254188) |
| January 24, 2026 | K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | Brazil | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252753) |
| January 16, 2026 | K251353 | Eyer 2 | Phelcom Technologies | Brazil | Substantially Equivalent | 510(k) traditional | HKI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251353) |
| January 7, 2026 | K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252727) |
| December 19, 2025 | K251050 | Pectus Versa System | Gm Dos Reis Industria E Comercio | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251050) |
| December 12, 2025 | K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | Brazil | Substantially Equivalent | 510(k) traditional | NHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252273) |
| December 12, 2025 | K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252090) |
| November 7, 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251129) |
| November 4, 2025 | K252664 | GMReis Suture Anchors | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | MBI | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252664) |
| October 31, 2025 | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327)... | Vigodent Indústria E Comercio Ltda | Brazil | Substantially Equivalent | 510(k) traditional | ELW | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253501) |
| October 17, 2025 | K252266 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252266) |
| September 26, 2025 | K251262 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251262) |
| September 19, 2025 | K242859 | VEGA | Ibramed Equipamentos Médicos | Brazil | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242859) |
| September 10, 2025 | K250464 | Enlight 2100 (TPL-E2103-0) | Timpel S.A. | Brazil | Substantially Equivalent | 510(k) traditional | QEB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250464) |
| August 18, 2025 | K250271 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250271) |
| August 14, 2025 | K243905 | Stitch Cerclage – Suture Tapes | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | JDQ | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243905) |
| August 13, 2025 | K251046 | S.I.N. Dental Implant System | S.I.N. Implant System Ltda | Brazil | Substantially Equivalent | 510(k) traditional | DZE | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251046) |
| June 12, 2025 | K250559 | GMReis Fibula Nail System | Gm Dos Reis Industria E Comercio | Brazil | Substantially Equivalent | 510(k) traditional | HSB | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250559) |
| May 27, 2025 | K250614 | Neodent Implant System - Custom Abutments | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250614) |
| April 22, 2025 | K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | Brazil | Substantially Equivalent | 510(k) traditional | EBG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243621) |
| January 29, 2025 | K243740 | Versalock Upper Limb Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243740) |
| December 20, 2024 | K242534 | HandPICO Fractional Laser Handpiece Tip | Vydence Medical | Brazil | Substantially Equivalent | 510(k) traditional | GEX | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242534) |
| December 19, 2024 | K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | Brazil | Substantially Equivalent | 510(k) traditional | NHN | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232813) |
| December 4, 2024 | K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | Brazil | Substantially Equivalent | 510(k) traditional | NHA | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242686) |
| November 26, 2024 | K231859 | PrimmaArt | Dentscare Ltda | Brazil | Substantially Equivalent | 510(k) traditional | EBG | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231859) |
| November 21, 2024 | K242998 | GMReis Ankle Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242998) |
| November 21, 2024 | K242596 | Versalock Mini and Micro Plating System | GM Dos Reis Industria e Comercio Ltda. | Brazil | Substantially Equivalent | 510(k) traditional | HRS | [accessdata.fda.gov](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K242596) |

## Applicants with the most decisions

| Applicant | Decisions | Latest |
| --- | --- | --- |
| GM Dos Reis Industria e Comercio Ltda. | 10 | August 22, 2026 |
| S.I.N. Implant System Ltda | 5 | October 22, 2026 |
| JJGC Indústria e Comércio de Materiais Dentários S.A. | 4 | July 1, 2026 |
| Gm Dos Reis Industria E Comercio | 2 | December 19, 2025 |
| Jjgc Indústria E Comércia DE Materiais Dentários S.A. | 2 | May 27, 2025 |
| Avanutri Equipamentos DE Saúde | 1 | May 29, 2026 |
| Ortobio S.A. | 1 | May 6, 2026 |
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 1 | April 23, 2026 |
| Vydence Medical Industria E Commercio Ltda | 1 | January 24, 2026 |
| Phelcom Technologies | 1 | January 16, 2026 |
| Dmc Importação E Exportação DE Equipamentos Ltda | 1 | December 12, 2025 |
| Vigodent Indústria E Comercio Ltda | 1 | October 31, 2025 |
| Ibramed Equipamentos Médicos | 1 | September 19, 2025 |
| Timpel S.A. | 1 | September 10, 2025 |
| Evoden Indústria Comércio Importação E Exportação | 1 | April 22, 2025 |
| Vydence Medical | 1 | December 20, 2024 |
| Dmc Importacao E Exportacao DE Equipamentos Ltda | 1 | December 19, 2024 |
| Dentscare Ltda | 1 | November 26, 2024 |

## By panel

| Panel | Decisions | Latest |
| --- | --- | --- |
| [Dental](https://specstream.ai/data/fda-clearances/panel/dental) | 14 | July 1, 2026 |
| [Orthopedic](https://specstream.ai/data/fda-clearances/panel/orthopedic) | 11 | August 19, 2026 |
| [General, Plastic Surgery](https://specstream.ai/data/fda-clearances/panel/general-plastic-surgery) | 5 | August 22, 2026 |
| [Physical Medicine](https://specstream.ai/data/fda-clearances/panel/physical-medicine) | 3 | May 29, 2026 |
| [General Hospital](https://specstream.ai/data/fda-clearances/panel/general-hospital) | 1 | October 22, 2026 |
| [Ophthalmic](https://specstream.ai/data/fda-clearances/panel/ophthalmic) | 1 | January 16, 2026 |
| [Anesthesiology](https://specstream.ai/data/fda-clearances/panel/anesthesiology) | 1 | September 10, 2025 |

## By decision type

| Decision type | Decisions | Latest |
| --- | --- | --- |
| [510(k) traditional](https://specstream.ai/data/fda-clearances/decision/510k-traditional) | 35 | October 22, 2026 |
| [510(k) special](https://specstream.ai/data/fda-clearances/decision/510k-special) | 1 | August 19, 2026 |

## Where FDA publishes these decisions

- [FDA 510(k) database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
- [FDA PMA database](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm)
- [openFDA device API](https://open.fda.gov/apis/device/)

Source: [openFDA device 510(k) and PMA (U.S. Food and Drug Administration)](https://open.fda.gov/apis/device/). CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).