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Futurabond M Single Dose

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K082753

by VOCO GmbH

Identifiers

510(k) Number
K082753 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Futurabond M Single Dose is a resin-based dental adhesive classified as an Agent, Tooth Bonding. It is designed to bond dental restorations to tooth structures, providing a durable and reliable seal for composite fillings, inlays, onlays, and other restorative materials. This adhesive ensures mechanical retention and chemical bonding to enhance the longevity of dental repairs.

The device is supplied as a single-dose unit, intended for one-time use per application. It is classified under Class II (Medical Device Regulation) and has received FDA 510(k) clearance, MDD, and MDR authorisations. Futurabond M Single Dose is non-sterile and must be handled in a clean environment. Storage should follow manufacturer guidelines to maintain product integrity, and it is intended for use in dental clinics and offices by trained dental professionals.

Frequently asked questions

Is Futurabond M Single Dose designed for use with specific types of dental restorations, and if so, which ones?

Yes, Futurabond M Single Dose is specifically designed to bond dental restorations to tooth structures, ensuring a durable seal for composite fillings, inlays, onlays, and other restorative materials. Its purpose is to provide mechanical retention and chemical bonding to enhance the longevity of these repairs.

How is Futurabond M Single Dose supplied, and is it intended for single-use only?

Futurabond M Single Dose is supplied as a single-dose unit, meaning each package is intended for one-time use per application. This design ensures sterility and usability for a single procedure, reducing the risk of contamination.

Is Futurabond M Single Dose sterile, and what storage conditions should be followed to maintain its integrity?

Futurabond M Single Dose is non-sterile, so it must be handled in a clean environment to prevent contamination. Storage should follow the manufacturer’s guidelines to preserve its effectiveness, though specific conditions (e.g., temperature, humidity) are not detailed in the provided data.

What regulatory pathways has Futurabond M Single Dose followed, and where is it authorized for use?

Futurabond M Single Dose has received FDA 510(k) clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) authorizations. These approvals confirm its compliance with dental adhesive standards in the U.S. and EU markets, though exact geographic availability beyond these regions isn’t specified.

Does Futurabond M Single Dose require any special handling or preparation before use?

While the data doesn’t specify exact preparation steps, as a resin-based dental adhesive, it likely requires proper mixing (if applicable) and application following standard dental bonding protocols. Since it’s non-sterile, clinicians should ensure the workspace is clean and adhere to manufacturer instructions for optimal performance.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (2)

  • FDA 510(k) K082753 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jul 29, 2026