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Futurabond Universal

by VOCO GmbH

510(k) K130486

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130486↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130486 Date20 Jun 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Futurabond Universal is a Tooth Bonding Agent, Resin, classified as a dental adhesive designed for bonding restorative materials to tooth structure. It functions as a universal adhesive system, enabling self-etch, selective-etch, or total-etch application techniques depending on clinical requirements. The product is formulated to bond with a variety of substrates, including light-, dual-, and self-cure resin composites, as well as metals, zirconia, and ceramics without requiring additional primers.

This adhesive is supplied in single-dose applications, ensuring sterility and ease of use in clinical settings. It is intended for both direct and indirect restorative procedures, offering versatility for dentists. The device is regulated under FDA 510(k) clearance and MDR, with a classification as a Class II medical device. Storage and handling follow standard dental adhesive protocols, and its compatibility with multiple curing methods enhances its clinical utility in adhesive dentistry.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of restorative materials can Futurabond Universal bond with, and how does this flexibility benefit clinicians?

    Futurabond Universal is designed as a universal adhesive system, allowing it to bond with a wide range of restorative materials, including light-, dual-, and self-cure resin composites, as well as metals, zirconia, and ceramics. This versatility eliminates the need for additional primers and enables clinicians to use self-etch, selective-etch, or total-etch techniques depending on the specific clinical requirements, streamlining workflow and improving adaptability for various restorative procedures.

  • Is Futurabond Universal supplied in a way that ensures sterility and convenience for clinical use?

    Yes, Futurabond Universal is supplied in single-dose applications, which guarantees sterility and simplifies handling in clinical settings. This packaging design reduces the risk of contamination and minimizes waste, making it practical for one-time use per patient.

  • What curing methods are compatible with Futurabond Universal, and why does this matter for dentists?

    Futurabond Universal is compatible with light-, dual-, and self-cure resin composites, meaning it can be used with multiple curing methods depending on the clinician’s preference or the specific restorative material being used. This compatibility enhances flexibility in treatment planning and ensures the adhesive can be effectively integrated into various adhesive dentistry protocols.

  • How should Futurabond Universal be stored, and what are the implications for clinical workflow?

    Futurabond Universal follows standard dental adhesive storage protocols, though specific storage instructions are not detailed in the provided data. Proper storage ensures the adhesive remains effective and safe for use. Clinicians should adhere to manufacturer guidelines to maintain product integrity, which is critical for reliable bonding performance and patient safety during procedures.