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Arabesk Flow

by VOCO GmbH

510(k) K994304

Active European Union and United States

CE MDR CE MDD 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) K994304↗

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 NumberK994304 Date7 Feb 2000ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
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  • Withdrawn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/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
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.

The Arabesk Flow is a dental composite resin flowable filling material, designed for restorative applications in dentistry. It is formulated to provide a smooth, high-viscosity flow that allows for easy placement and adaptation to tooth cavities while maintaining mechanical strength and aesthetic properties.

Supplied as a single-component system, Arabesk Flow is intended for use in dental offices and clinics, where it is applied directly to prepared tooth surfaces. The material is packaged in sterile, single-use syringes and is classified under the EU’s Medical Device Regulation (MDR) and the US FDA’s 510(k) pathway, with a clearance type designated as Traditional. Its product code is EBF, and it adheres to dental industry standards for restorative materials.

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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 types of dental restorations is Arabesk Flow designed for, and how does its flowable formulation benefit the clinician during placement?

    Arabesk Flow is specifically formulated as a dental composite resin filling material for restorative applications, particularly where a smooth, high-viscosity flow is advantageous. Its flowable consistency allows for easy adaptation to tooth cavities, simplifying placement in areas that require precise contouring—such as interproximal spaces or shallow preparations—while still delivering mechanical strength and aesthetic results comparable to traditional composites. This makes it ideal for layering, blending, or finishing restorations where traditional composites might be too rigid.

  • Is Arabesk Flow intended for direct use on prepared tooth surfaces, and if so, how is it supplied to ensure clinical convenience?

    Yes, Arabesk Flow is designed for direct application to prepared tooth surfaces in dental offices or clinics. It is supplied in sterile, single-use syringes, eliminating the need for mixing or contamination risks. This packaging ensures ease of handling, immediate clinical readiness, and compliance with infection control protocols, as each syringe is intended for one-time use only.

  • Are there multiple sizes or models of Arabesk Flow, and if so, how might a clinician determine which one to select for a specific restoration?

    The provided data does not specify multiple sizes or models for Arabesk Flow, implying it is offered as a single formulation within the product line. Clinicians should select it based on the restoration’s requirements—particularly for its flowable properties—rather than size variations. The high-viscosity flow ensures adaptability to various cavity preparations, making it versatile for general restorative use without the need for additional variants.

  • How should Arabesk Flow be stored, and what precautions should be taken to maintain its sterility and performance?

    Since Arabesk Flow is supplied in sterile, single-use syringes, it should be stored in a clean, dry environment protected from extreme temperatures, direct sunlight, and contamination. The manufacturer’s guidelines (not detailed here) would specify exact storage conditions, but generally, dental materials like this are kept in their original packaging until use. Once opened, the syringe should be used immediately to preserve sterility and material integrity, as flowable composites can degrade if exposed to air or improper storage.