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S.I.N. Implant System Ltda

Active in EUDAMED

Brazilfrom SRN EUDAMED FDA SRN BR-MF-000019848 FEI 3004201263

Devices
847
Registrations
EUDAMEDFDA
FDA recalls
11 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA FEI, FDA recalls

Catalogue847

Newest first, page 1 of 17

Showing 1-50 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
Phone
+55 11 21693236
PRRC contact
Denise Domiciano(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 3 Dec 2029

EUDAMED certificates (2)

DNV Product Assurance AS 2460 2 certificates

  • C751660 Amended

    Quality management system EU MDR

    Issued
    10 Jun 2026
    Expires
    4 Dec 2030
    Reason
    Ar srn change
  • C599375 Issued

    Quality management system EU MDR

    Issued
    4 Dec 2024
    Expires
    3 Dec 2029

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

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.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

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. Distribution: US Nationwide distribution including in the states of TX, IL, KY, NC, TN, CO, CA, MO, MD, AL, FL, PA, UT, NE, ID, AZ,…
      Full distribution text US Nationwide distribution including in the states of TX, IL, KY, NC, TN, CO, CA, MO, MD, AL, FL, PA, UT, NE, ID, AZ, WA, OK, OR, NV, NJ, VA, NY, LA, CT, SD, SC, HI, KS, MA, MI, NM, OH, MT, WI, MN, ME.

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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.

Which registries list S.I.N. Implant System Ltda's devices?

Among its 50 most recently registered devices, S.I.N. Implant System Ltda has devices listed in EUDAMED (50 devices).

What risk classes do S.I.N. Implant System Ltda's devices fall under?

Among its 50 most recently registered devices, the classes recorded for S.I.N. Implant System Ltda's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.

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 2025-07-30. 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 2026-06-10.

What are the newest devices from S.I.N. Implant System Ltda in the registry?

The most recently registered devices listed for S.I.N. Implant System Ltda include IMP. EPIKUT HE Ø3.75X8.5MM, FIXATION SCREW ABUT.MINI HI ALT.4MM, ABUT. INTERFACE HE Ø3.4X2.5MM IND. and ABUT. PRE MILLED Ø12MM HE Ø4.1 AG.

Generated automatically from registry data and not verified by a human reviewer.