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FDA 510(k)

S.I.N. Tapered Pro Conical Zygoma Implant System

K-Number: K251129 · 2025-11-07

ApplicantS.I.N. Implant System Ltda
Decision Date2025-11-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.I.N. Tapered Pro Conical Zygoma Implant System is a medical device manufactured by S.I.N. Implant System Ltda. It received FDA 510(k) clearance on 2025-11-07 under approval number K251129. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S.I.N. Tapered Pro Conical Zygoma Implant System?

S.I.N. Tapered Pro Conical Zygoma Implant System is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by S.I.N. Implant System Ltda. The 510(k) number is K251129.

When was S.I.N. Tapered Pro Conical Zygoma Implant System approved by the FDA?

S.I.N. Tapered Pro Conical Zygoma Implant System received FDA 510(k) clearance on 2025-11-07, under approval number K251129.

What company makes S.I.N. Tapered Pro Conical Zygoma Implant System?

S.I.N. Tapered Pro Conical Zygoma Implant System is manufactured by S.I.N. Implant System Ltda.

What is the FDA product code for S.I.N. Tapered Pro Conical Zygoma Implant System?

The FDA product code for S.I.N. Tapered Pro Conical Zygoma Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by S.I.N. Implant System Ltda

K252266S.I.N. Dental Implant System K251262S.I.N. Dental Implant System K251046S.I.N. Dental Implant System

Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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