S.I.N. Implant System Ltda
Active in EUDAMEDBrazilfrom SRN EUDAMED FDA SRN BR-MF-000019848 FEI 3004201263
- Devices
- 847
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
What S.I.N. Implant System Ltda makes
S.I.N. Implant System Ltda manufactures dental implant systems, including standard and tapered conical designs, as well as zygoma implants for complex cases. These products are intended for osseointegrated fixation in the jawbone, supporting prosthetic restorations. The portfolio includes both conventional and specialized implants for patients requiring additional stability or anatomical adaptation.
The company’s dental implant systems fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) clearance through the FDA. These devices are listed under the 510(k) pathway, ensuring compliance with US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 847 devicesShowing 551-600 of 847
Company details
- EUDAMED SRN
- BR-MF-000019848
- FDA FEI number
- 3004201263
- EUDAMED status
- Active
- EUDAMED registered name
- S.I.N. Implant System Ltda.
- EUDAMED abbreviated name
- S.I.N. Implant System Ltda.
- Registered address
- 421, Rua Soldado Ocimar Guimaraes da Silva, 03348-060, Sao Paulo, Brazil
- Website
- www.sinimplantsystem.com.br/
- [email protected]
- Phone
- +55 11 21693236
- PRRC contact
- Denise Domiciano
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 3 Dec 2029
DNV Product Assurance AS 2460 2 certificates
- C751660 Active
Quality management system EU MDR
- Issued
- 10 Jun 2026
- Expires
- 4 Dec 2030
- Reason
- Ar srn change
- C599375 Active
Quality management system EU MDR
- Issued
- 4 Dec 2024
- Expires
- 3 Dec 2029
FDA recalls
FDA recall records list 1 recall initiated by S.I.N. Implant System Ltda, initiated on 2025-07-30. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use, packaging and performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 30 Jul 2025 Z-0017-2026 Class II Ongoing 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.
Full distribution text
- 30 Jul 2025 Z-0017-2026 Class II Ongoing 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.
Frequently asked questions
How many devices does S.I.N. Implant System Ltda have in the registry?
The registry currently lists 847 devices for S.I.N. Implant System Ltda. Devices recorded under merged duplicate company entries are counted once.
Are there FDA recall records for S.I.N. Implant System Ltda?
FDA recall records list 1 recall initiated by S.I.N. Implant System Ltda, the most recent initiated on 30 Jul 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for S.I.N. Implant System Ltda?
EUDAMED lists 2 certificates for S.I.N. Implant System Ltda (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 10 Jun 2026.