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Solobond Plus

by VOCO GmbH

510(k) K003153

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) K003153↗

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 NumberK003153 Date15 Nov 2000ClearedStatusActive
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  • Withdrawn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, 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.

Solobond Plus is a light-curing two-stage universal bonding agent classified as an Agent, Tooth Bonding, Resin. It is designed to create a durable bond between hard tooth structures (dentin and enamel) and composite restorative materials, ensuring minimal marginal leakage for long-term stability.

This device is supplied as a dual-component system—consisting of a Primer and an Adhesive—intended for use in dental settings. It is single-use, non-sterile, and requires separate tooth surface etching prior to application. Authorized under FDA 510K and MDR, Solobond Plus adheres to Class II regulatory standards for dental adhesives, with no MRI safety restrictions. Storage follows manufacturer guidelines as specified in the instructions for use.

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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 the primary purpose of Solobond Plus in dental procedures?

    Solobond Plus is designed as a universal bonding agent to create a strong, durable bond between hard tooth structures (dentin and enamel) and composite restorative materials. This helps minimize marginal leakage, ensuring long-term stability of dental restorations.

  • Is Solobond Plus intended for single-use or reusable applications?

    Solobond Plus is explicitly labeled as a single-use device. Each application requires a new set of the dual-component system (Primer and Adhesive) to maintain sterility and performance.

  • Does Solobond Plus come pre-sterilized, or is it non-sterile?

    Solobond Plus is supplied in a non-sterile state. It must be handled according to the manufacturer’s instructions for use, which likely include sterilization procedures for the tooth surface prior to application.

  • What regulatory pathways has Solobond Plus followed for approval?

    Solobond Plus has been authorized through the FDA’s 510(k) pathway (traditional clearance) and complies with the EU’s Medical Device Regulation (MDR). It falls under Class II regulatory standards for dental adhesives in the U.S.

  • Are there any special handling or storage requirements for Solobond Plus?

    While the exact storage conditions are detailed in the manufacturer’s instructions for use, Solobond Plus must be stored as directed by VOCO GmbH to preserve its efficacy. It is not pre-sterilized, so proper handling and environmental controls are necessary before use.