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ET III SA Ultra Wide System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103537

by Hiossen, Inc.

Identifiers

510(k) Number
K103537 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 ET III SA Ultra Wide System is a dental implant system component featuring a sand-blasted and acid-etched (SA) surface and an internal hex connection. It is part of the ET Implant System designed for use in dental applications.

The device is supplied as part of the ET III SA Ultra Wide System by Hiossen, Inc. and has received FDA 510(k) clearance under K103537. It is indicated for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations including cement-retained, screw-retained, or overdenture restorations.

Frequently asked questions

What is the ET III SA Ultra Wide System used for?

The ET III SA Ultra Wide System is indicated for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations, including cement-retained, screw-retained, or overdenture restorations, as part of the ET Implant System.

How is the ET III SA Ultra Wide System supplied and what are its key features?

The device is supplied as a component of the ET III SA Ultra Wide System by Hiossen, Inc., featuring a sand-blasted and acid-etched (SA) surface and an internal hex connection for dental implant applications.

What regulatory pathway was used for the ET III SA Ultra Wide System?

The ET III SA Ultra Wide System received FDA 510(k) clearance under submission number K103537, indicating it was found substantially equivalent to a legally marketed predicate device.

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: ET III SA Ultra-Wide Implant - eshop.hiossen.com, ET Implant System - Hiossen® Implant, ET SA Dental Implant System & Surface Technology | Hiossen, ET III SA ULTRA WIDE SYSTEM by HIOSSEN INC. | FDA 510(k) Summary, Hiossen ETIII SA System Implant Review

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K103537 24 fields · synced Sep 26, 2026