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ET IV SA Dental Implants

FDA 510(k)

Class II (US FDA 510(k))

510(k) K183242

by Hiossen, Inc.

Identifiers

510(k) Number
K183242 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)

ET IV SA Dental Implants are dental implants designed for use in sinus lift, soft bone, and immediate cases. The implants feature a 6° angled taper body design that provides strong initial stability in soft bone conditions.

The ET IV SA Dental Implants are supplied as part of the ET System and are intended for dental implant surgery. They are authorized under FDA 510K clearance with product code DZE and are manufactured by Hiossen, Inc.

Frequently asked questions

What are ET IV SA Dental Implants designed for?

ET IV SA Dental Implants are designed specifically for use in sinus lift procedures, soft bone conditions, and immediate implant cases. Their 6° angled taper body design provides strong initial stability in challenging bone environments.

How are ET IV SA Dental Implants supplied?

The ET IV SA Dental Implants are supplied as part of the ET System, which includes all necessary components for dental implant surgery. They are manufactured by Hiossen, Inc. and are available in various models to suit different clinical needs.

What is the regulatory status of ET IV SA Dental Implants?

ET IV SA Dental Implants are authorized under FDA 510K clearance with product code DZE. They received FDA clearance on May 21, 2019, after being filed on November 21, 2018, and are classified under the Dental advisory committee.

What makes ET IV SA Dental Implants suitable for soft bone conditions?

The implants feature a 6° angled taper body design that enhances primary stability in soft bone conditions. This design allows for better initial fixation in less dense bone, making them particularly suitable for challenging cases where traditional implants might struggle to achieve adequate stability.

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: PDF Hiossen ET Implant System, IMPLANTS - ET SYSTEM - ET IV - Hiossen Implant Canada, Hiossen ET™ System Dental Implant - Manufacturer - Ritter Implants, ET Implant System - Insight Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K183242 24 fields · synced Sep 22, 2026