← Back to catalogue

Hiossen Implant System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140934

by Hiossen, Inc.

Identifiers

510(k) Number
K140934 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 Hiossen Implant System is a dental implant system used for dental procedures. It is designed to provide a foundation for artificial teeth and is part of the next generation of tapered implant technology.

The system is supplied by Hiossen, Inc. and is authorized under FDA 510K clearance with product code DZE. It is intended for use in dental settings and is available in various sizes and models as specified by the manufacturer.

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: Dental Implant Systems, Equipment & Education | Hiossen, Dental Implant Products | Hiossen® Implant, Hiossen eShop, Hiossen Zahnimplantate | SpotImplant

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hiossen, Inc.

Sources (1)

  • FDA 510(k) K140934 24 fields · synced Sep 22, 2026