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Implantium II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K060501

by Dentium Co., Ltd.

Identifiers

510(k) Number
K060501 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 classified under the nomenclature category DZE (Dental Implant, Endosseous, Single Tooth Replacement). It is designed for osseointegration within the jawbone, providing a stable foundation for single-tooth restorations or immediate loading protocols. Its dual-thread and coronal microthread geometry enhances primary stability by distributing load across cortical and cancellous bone, ensuring secure integration.

Implantium II is supplied sterile and intended for single-use in oral and maxillofacial surgical settings. The device is approved under FDA 510(k) clearance (K060501) as substantially equivalent to a predicate device, with a decision date of June 16, 2006. Available in standard diameters, it requires proper sterilization handling and storage per manufacturer guidelines to maintain biocompatibility and performance. No MRI safety information is specified.

Frequently asked questions

What types of dental restorations can the Implantium II support, and how does its design help with stability?

The Implantium II is specifically designed for single-tooth restorations, including immediate loading protocols. Its dual-thread and coronal microthread geometry enhances primary stability by distributing mechanical load across both the cortical (dense outer) and cancellous (spongy inner) bone of the jaw. This design helps ensure a secure foundation for the restoration, reducing the risk of early failure or loosening.

Is the Implantium II intended for reuse, or is it meant to be used only once per patient?

The Implantium II is explicitly labeled for single-use only in oral and maxillofacial surgical settings. This classification aligns with standard dental implant protocols to prevent cross-contamination and ensure patient safety. Reusing the device would violate manufacturer guidelines and could compromise sterility and biocompatibility.

What storage and handling precautions should be taken to maintain the device’s sterility and performance?

The Implantium II is supplied sterile, so it must be stored according to the manufacturer’s guidelines to preserve sterility and biocompatibility. This includes keeping it in a sealed, dry environment away from direct sunlight or extreme temperatures. Proper handling—such as avoiding contamination during unpacking—is critical, as the device is not designed for reprocessing or reuse. Follow Dentium’s instructions to ensure optimal performance.

Are there different sizes or models available for the Implantium II, and how do I determine the right fit for a patient?

The Implantium II is available in standard diameters, but exact sizing options are not detailed in the provided data. Selection should be based on the patient’s anatomical assessment (e.g., jawbone density, available space) and the surgeon’s clinical judgment. Radiographic evaluation and consultation with the manufacturer’s sizing guidelines are recommended to choose the appropriate implant for optimal osseointegration and 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: Implantium - Implant - Product - Dentium, Implantium Implants - Dentium USA, Implantium - Dentium Europe, Dentium Implantium II Dental Implant | SpotImplant - None

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) K060501 24 fields · synced Sep 19, 2026