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S.I.N. Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193096

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

Identifiers

510(k) Number
K193096 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 device designed for osseointegrated fixation in the jawbone to support prosthetic restorations. Classified under the product code DZE, it is intended for use in dental implantology to replace missing teeth by providing stable anchorage for crowns, bridges, or dentures. The system is engineered to facilitate predictable outcomes in single-tooth and full-arch reconstructions, leveraging precision engineering for biocompatibility and mechanical stability.

This system is supplied as a sterile, single-use implant device, intended for use in clinical settings by trained dental professionals. It is available in various sizes and configurations to accommodate different anatomical requirements, including full-arch solutions. The device is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to predicate devices. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical use.

Frequently asked questions

What is the S.I.N. Dental Implant System used for?

The S.I.N. Dental Implant System is designed for osseointegrated fixation in the jawbone to replace missing teeth. It provides stable anchorage for prosthetic restorations such as crowns, bridges, or dentures, ensuring predictable outcomes in both single-tooth and full-arch dental reconstructions. Its precision engineering supports biocompatibility and mechanical stability, making it suitable for long-term dental restoration.

Is the S.I.N. Dental Implant System sterile and single-use?

Yes, the S.I.N. Dental Implant System is supplied as a sterile, single-use device. This ensures patient safety and maintains the integrity of the implant during surgical procedures, as it is intended for one-time clinical use only by trained dental professionals.

What sizes and configurations are available for the S.I.N. Dental Implant System?

The S.I.N. Dental Implant System is available in multiple sizes and configurations to accommodate various anatomical requirements. This includes options for both single-tooth replacements and full-arch solutions, allowing for customized treatment plans based on patient-specific needs.

How should the S.I.N. Dental Implant System be stored?

The S.I.N. Dental Implant System must be stored and handled according to sterile medical device protocols to preserve its integrity before surgical use. Proper storage conditions are critical to maintaining sterility and ensuring the device remains ready for clinical application when needed.

What regulatory pathway does the S.I.N. Dental Implant System follow?

The S.I.N. Dental Implant System is regulated under the FDA’s 510(k) pathway, with clearance granted as substantially equivalent to predicate devices. This pathway ensures that the device meets established safety and effectiveness standards for dental implants, as determined by the FDA’s review process.

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) K193096 24 fields · synced Oct 1, 2026