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S.I.N. Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211921

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

Identifiers

510(k) Number
K211921 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 implant system designed for use in implant dentistry. It provides a variety of implant solutions for clinical needs, including full arch applications.

This device is authorized under FDA 510K clearance K211921. It 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 implant dentistry to provide a variety of implant solutions. It is specifically indicated to support clinical needs, including the application of full arch restorations.

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

Yes, this device is authorized under FDA 510K clearance number K211921. This indicates that the system has been reviewed and found 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. | Soluciones + Innovaciones = Nuevas Sonrisas, Home - S.I.N. 360, 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) K211921 24 fields · synced Sep 26, 2026