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S.I.N. Dental Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221453

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

Identifiers

510(k) Number
K221453 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 restoration of missing teeth. It comprises implant fixtures, abutments, and prosthetic components intended to support dental prostheses in the oral cavity, adhering to dental implant nomenclature standards.

This system is supplied sterile for single-use and is intended for use in clinical dental settings by trained professionals. It is classified under product code DZE and holds FDA 510(k) clearance as substantially equivalent to a predicate device, ensuring compliance with regulatory requirements for dental implants. Sizes and configurations are specified in the manufacturer’s technical documentation.

Frequently asked questions

What types of dental restorations can the S.I.N. Dental Implant System support in the oral cavity?

The S.I.N. Dental Implant System is designed to support osseointegrated dental prostheses, meaning it can be used to restore single missing teeth, bridges, or full dentures. The system includes implant fixtures, abutments, and prosthetic components that work together to anchor these restorations securely in the jawbone.

Is the S.I.N. Dental Implant System intended for reuse, or is it meant to be used only once?

The S.I.N. Dental Implant System is supplied sterile for single-use only. This ensures patient safety and compliance with clinical dental standards, as reuse could compromise sterility and integrity.

How do I determine the correct size or configuration for a patient’s implant needs?

The available sizes and configurations for the S.I.N. Dental Implant System are detailed in the manufacturer’s technical documentation. Since dental anatomy varies, a trained dental professional should consult these specifications to select the appropriate fixture, abutment, or prosthetic component for each patient’s specific case.

What regulatory pathway does the S.I.N. Dental Implant System follow, and what does that mean for its use?

The S.I.N. Dental Implant System holds FDA 510(k) clearance under product code DZE, meaning it has been deemed substantially equivalent to a predicate device through the traditional review process. This clearance confirms it meets U.S. regulatory standards for dental implants, ensuring safety and performance when used by trained professionals in clinical settings.

How should the S.I.N. Dental Implant System be stored to maintain its sterility and usability?

Since the system is supplied sterile for single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions to preserve sterility until immediate clinical use.

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, 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.
FDA Applicant
S.I.N. – Sistema DE Implante Nacional S.A.

Sources (1)

  • FDA 510(k) K221453 24 fields · synced Sep 19, 2026