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IONOLUX PRO

by VOCO GmbH

510(k) K102450

Active European Union and United States

CE MDR 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) K102450↗

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 · Special NumberK102450 Date8 Oct 2010ClearedStatusActive
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  • Withdrawn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
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.

IONOLUX PRO is a resin-modified glass ionomer restorative material, classified as a dental restorative material under the FDA’s product code EBF. It combines the benefits of glass ionomers with resin reinforcement, delivering composite-like aesthetics, high radiopacity, and immediate packability after application. The material is designed for direct restoration of dental cavities, offering fluoride release to help prevent secondary caries while maintaining excellent translucency for natural-looking results.

IONOLUX PRO is supplied as a two-component system requiring mixing before use and is light-cured for rapid setting. It is intended for single-use applications in dental settings and does not require conditioning of dental hard tissues. The material is highly radiopaque, ensuring clear visibility on radiographs, and is immediately packable after placement. Authorized under FDA 510(k) clearance (K102450) and MDR compliance, it adheres to regulatory standards for dental restorative materials.

Other devices from VOCO GmbH

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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 cavities is IONOLUX PRO designed to restore, and why is it preferred over traditional glass ionomers?

    IONOLUX PRO is designed for direct restoration of dental cavities, particularly where aesthetics and durability are important. Unlike traditional glass ionomers, it combines resin reinforcement to provide composite-like aesthetics, high radiopacity for clear radiographic visibility, and immediate packability after application. Its fluoride release also helps prevent secondary caries, making it suitable for posterior and anterior restorations where a natural appearance and long-term protection are desired.

  • How is IONOLUX PRO supplied, and what steps are required before use?

    IONOLUX PRO is supplied as a two-component system that requires mixing before use. Since it is light-cured, the mixed material must be placed in the cavity and cured with a dental light to achieve rapid setting. The material does not require any conditioning of dental hard tissues, simplifying the application process for clinicians.

  • Is IONOLUX PRO intended for single-use or reusable applications, and how should it be stored?

    IONOLUX PRO is explicitly designed for single-use applications in dental settings. While storage instructions are not detailed in the provided data, typical resin-modified glass ionomers should be stored in a cool, dry place away from direct sunlight to preserve material properties until use.

  • What regulatory pathways has IONOLUX PRO followed, and what does this mean for its use in clinical practice?

    IONOLUX PRO has undergone FDA 510(k) clearance (K102450) under the Special 510(k) pathway, classified as substantially equivalent to a predicate device, and complies with the EU Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness according to regulatory standards, allowing authorized use in dental restorative procedures in the U.S. and EU markets where applicable.