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Nobelactive Multi Unit Abutment

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K072570

by Nobel Biocare AB

Identifiers

510(k) Number
K072570 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nobelactive Multi Unit Abutment is a dental implant abutment designed for use in endosseous implant systems. It serves as a connector between dental implants and prosthetic crowns or bridges, facilitating the restoration of both fully and partially edentulous arches, particularly in multi-tooth reconstructions.

This abutment is supplied as a reusable component for dental professionals in clinical settings. It is classified under the NHA product code for dental implant abutments and prosthetic components, with FDA 510(k) clearance and MDD authorization. No specific sterility or MRI safety information is provided in the data, and sizes or additional technical specifications are not detailed.

Frequently asked questions

Is the Nobelactive Multi Unit Abutment intended for single-tooth or multi-tooth dental restorations, and how does it differ in its application?

The Nobelactive Multi Unit Abutment is specifically designed for multi-tooth reconstructions, serving as a connector between dental implants and prosthetic crowns or bridges. This makes it ideal for restoring both fully and partially edentulous arches where multiple teeth are involved, unlike single-tooth abutments which are tailored for individual implants.

How is the Nobelactive Multi Unit Abutment supplied to dental professionals, and is it intended for single-use or reuse?

The Nobelactive Multi Unit Abutment is supplied as a reusable component for clinical use by dental professionals. Unlike single-use devices, it is meant to be cleaned, sterilized, and reused in multiple procedures, which is common for dental implant components to ensure cost-effectiveness and reduce waste.

What regulatory pathways has the Nobelactive Multi Unit Abutment followed, and what does this mean for its use in clinical settings?

The Nobelactive Multi Unit Abutment has obtained FDA 510(k) clearance and MDD authorization, indicating it has been evaluated and deemed substantially equivalent to a legally marketed predicate device under the FDA’s traditional clearance process. This means it meets regulatory standards for safety and effectiveness in its intended use as a dental implant abutment for multi-unit restorations.

Are there specific sizes or technical specifications provided for the Nobelactive Multi Unit Abutment, or is it a standardized component?

The provided data does not include specific sizes or detailed technical specifications for the Nobelactive Multi Unit Abutment. However, as a dental implant abutment, it is likely designed to fit standard implant platforms and prosthetic systems, allowing for customization based on clinical needs. For precise sizing, consulting the manufacturer’s catalog or technical documentation is recommended.

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: Multi-unit Abutment | Nobel Biocare, NOBELACTIVE MULTI UNIT ABUTMENT (K072570) — FDA 510 (k) | Innolitics, Multi-unit Abutment: Key to the original All-on-4® treatment concept, K072570 FDA 510(k) - NOBELACTIVE MULTI UNIT ABUTMENT

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nobel Biocare AB

Sources (2)

  • FDA 510(k) K072570 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026