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S.I.N. Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240609

by S.I.N. - Sistema DE Implante Nacional S.A.

Identifiers

510(k) Number
K240609 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The S.I.N. Dental Implant System is a dental device designed for use in implantology. It provides a variety of implant solutions intended to support dental restorations.

This system is authorized under FDA 510K clearance, identified by K number K240609. The device is manufactured by S.I.N. - Sistema DE Implante Nacional S.A. based in São Paulo, Brazil.

Frequently asked questions

What is the intended use of the S.I.N. Dental Implant System?

The S.I.N. Dental Implant System is designed for use in the field of implantology. It provides a variety of implant solutions specifically intended to support dental restorations for patients.

Is the S.I.N. Dental Implant System authorized for use?

Yes, this device is authorized under FDA 510K clearance, identified by K number K240609. This indicates that the system has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Who is the manufacturer of this dental implant system?

The S.I.N. Dental Implant System is manufactured by S.I.N. - Sistema DE Implante Nacional S.A., which is based in São Paulo, Brazil.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home - S.I.N. | Solutions + Innovations = New Smiles, Home - S.I.N. 360, Our Purpose - S.I.N. | Solutions + Innovations = New Smiles, S.I.N Implant System (SIN) Dental Implants | SpotImplant

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
S.I.N. - Sistema DE Implante Nacional S.A.

Sources (1)

  • FDA 510(k) K240609 24 fields · synced Sep 25, 2026