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ET III Bio-SA Fixture System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151626

by Hiossen, Inc.

Identifiers

510(k) Number
K151626 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 Bio-SA Fixture System is a dental implant fixture classified under the nomenclature category DZE (Dental Implant Fixture). It is designed for use in partially or fully edentulous mandibles and maxillae, providing a stable foundation for dental prosthetics. The system features a sand-blasted and acid-etched (SA) surface to enhance osseointegration and an internal hex connection for secure attachment.

This system is supplied as a sterile, single-use device intended for surgical placement by dental professionals. It is regulated under the FDA 510(k) clearance (K151626) and falls under the Dental Advisory Committee (DE) review panel. The fixture is intended for use in controlled clinical settings and must be handled according to standard aseptic techniques. No additional regulatory markings beyond the FDA clearance are stated.

Frequently asked questions

What types of dental conditions is the ET III Bio-SA Fixture System designed to address in patients?

The ET III Bio-SA Fixture System is specifically designed for patients who are partially or fully missing teeth in either the lower jaw (mandibles) or upper jaw (maxillae). It provides a stable foundation for dental prosthetics, such as crowns or bridges, by integrating with the bone structure through its sand-blasted and acid-etched (SA) surface, which promotes stronger osseointegration.

Is the ET III Bio-SA Fixture System intended for reuse, or is it meant to be used only once per patient?

The ET III Bio-SA Fixture System is supplied as a sterile, single-use device. This means it is intended for one-time surgical placement per patient and should not be reused, even after sterilization, to maintain patient safety and compliance with aseptic techniques.

How is the ET III Bio-SA Fixture System secured in place, and what advantages does this method offer?

The system uses an internal hex connection to securely attach the fixture to the dental prosthetic, ensuring stability. The sand-blasted and acid-etched (SA) surface further enhances osseointegration, which is the process where bone grows directly onto the fixture, providing a stronger and more reliable foundation for the prosthetic.

What kind of regulatory approval does the ET III Bio-SA Fixture System have, and how was it reviewed?

The ET III Bio-SA Fixture System holds FDA 510(k) clearance under the reference number K151626. It was reviewed by the Dental Advisory Committee (DE) and classified as substantially equivalent to a predicate device, following a traditional clearance process. This means it was evaluated to ensure it meets the same safety and performance standards as existing dental implant fixtures.

How should the ET III Bio-SA Fixture System be stored before use to ensure its sterility and integrity?

Since the system is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. The packaging should remain intact until immediately before use to preserve sterility and prevent contamination.

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 Implant System - Hiossen® Implant, ET III SA Regular Implant - eshop.hiossen.com, ET III Bio-SA Fixture System (K151626) — FDA 510(k) | Innolitics, PDF Hiossen ET Implant System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K151626 24 fields · synced Sep 19, 2026