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Implantium II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171126

by Dentium Co., Ltd.

Identifiers

510(k) Number
K171126 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 Implantium II is a dental implant device. It features a dual-thread and coronal microthread design that ensures even load distribution across cortical and cancellous bone, providing smooth insertion torque and secure primary stability, even in immediate loading or single-tooth cases.

The device is supplied by Dentium Co., Ltd. and has received FDA 510(k) clearance under K-number K171126 with product code DZE. It is intended for use in dental applications as indicated by the advisory committee classification DE.

Frequently asked questions

What is the Implantium II dental implant used for?

The Implantium II is a dental implant device intended for use in dental applications, providing secure primary stability and even load distribution in cortical and cancellous bone, suitable for immediate loading or single-tooth cases as indicated by its advisory committee classification DE.

How is the Implantium II supplied and what is its regulatory status?

The Implantium II is supplied by Dentium Co., Ltd. and has received FDA 510(k) clearance under K-number K171126 with product code DZE, determined to be substantially equivalent to a predicate device.

What design features does the Implantium II have to ensure stability during insertion?

The Implantium II features a dual-thread and coronal microthread design that ensures even load distribution across cortical and cancellous bone, providing smooth insertion torque and secure primary stability, even in immediate loading or single-tooth cases.

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: Implantium - Implant - Product - Dentium, Implantium Implants - Dentium USA, Implantium - Dentium Europe, Implantium II - Dentium - PDF Catalogs | Technical Documentation

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dentium Co., Ltd.

Sources (1)

  • FDA 510(k) K171126 24 fields · synced Sep 26, 2026