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Futurabond NR

by VOCO GmbH

510(k) K042670

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

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) K042670↗

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 NumberK042670 Date1 Nov 2004ClearedStatusActive
European UnionCE/MDD 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  • Withdrawn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/MDD 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, 18 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 NR is a resin-based dental bonding agent designed for adhesive bonding of restorative materials to tooth structure. It is classified as an Agent, Tooth Bonding, Resin, adhering to regulatory standards for dental adhesives under the nomenclature system.

This single-use device is supplied in sterile form and intended for use in dental settings. It requires no sterilisation between applications and is regulated under the EU Medical Device Directive (MDD) and has received FDA 510(k) clearance as substantially equivalent to a predicate device. The product is available in specific batch codes and adheres to the regulatory requirements outlined in 872.3200.

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Questions

AI-generated answers, 18 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 is Futurabond NR used for in dental procedures?

    Futurabond NR is a resin-based dental bonding agent specifically designed to create a strong adhesive bond between restorative materials (like fillings or crowns) and tooth structure. It helps ensure the longevity and stability of dental restorations by promoting adhesion at the tooth-material interface.

  • Is Futurabond NR single-use or reusable, and does it require sterilization between applications?

    Futurabond NR is explicitly labeled as a single-use device, meaning each application should use a new unit. Since it is supplied in sterile form, no additional sterilization is required between uses, simplifying its workflow in clinical settings.

  • What regulatory pathways has Futurabond NR followed, and how does this affect its use?

    Futurabond NR has received FDA 510(k) clearance as substantially equivalent to a predicate device, confirming its compliance with U.S. dental adhesive standards. It is also authorized under the EU Medical Device Directive (MDD), ensuring its suitability for use in both regulated markets. These clearances validate its safety and performance for adhesive bonding in dental restorations.

  • How should Futurabond NR be stored, and are there specific batch codes to note?

    While the data does not specify storage conditions beyond standard medical device guidelines, Futurabond NR is supplied in sterile form and comes with multiple batch codes (e.g., 3038718579, 3008882689, etc.). Clinicians should verify the batch code for traceability and ensure proper handling as per manufacturer instructions to maintain sterility and efficacy.