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Polibond

by Zirkonzahn SRL

510(k) K232691

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) K232691↗

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 NumberK232691 Date5 Sep 2023ClearedStatusActive
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  • Withdrawn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
EBI
Device class
Class II
Regulation
21 CFR Part 872.3760
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.

Polibond is a dental adhesive designed for bonding composite resins. It facilitates the secure attachment of resin-based materials, including Abro Basic Mono, Abro Basic Multistratum, and Denture Gingiva variants, to dental substrates.

This adhesive is supplied as a single-use product and is intended for use in dental clinical settings. It complies with FDA 510(k) clearance under the Traditional pathway and is classified under the MDR framework. No specific sterility or MRI safety information is provided in the data.

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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 materials can Polibond be used to bond, and why is this adhesive specifically recommended for those materials?

    Polibond is designed to securely bond composite resins such as Abro Basic Mono, Abro Basic Multistratum, and Denture Gingiva variants to dental substrates. It is specifically formulated to enhance adhesion between these resin-based materials and teeth or dental restorations, ensuring a strong and durable bond for restorative or aesthetic procedures.

  • Is Polibond intended for single-use or repeated use in a clinical setting, and what does this mean for cost management?

    Polibond is supplied as a single-use product, meaning each application requires a new unit. This design ensures sterility and hygiene per clinical standards, but it also impacts cost management as clinicians must account for the consumption of one unit per procedure rather than reusing a single bottle.

  • How is Polibond classified under regulatory frameworks, and what does this classification imply for its use in dental practices?

    Polibond is classified under the FDA 510(k) Traditional pathway with a Substantially Equivalent determination (decision code: SESE) and falls under the MDR (Medical Device Regulation) framework in Europe. This means it has undergone regulatory review to confirm its safety and effectiveness compared to existing dental adhesives, allowing it to be legally marketed and used in clinical settings where such clearance or conformity is required.

  • What should clinicians know about the storage or handling of Polibond before use in a dental procedure?

    The provided data does not specify storage conditions or handling instructions for Polibond, so clinicians should refer to the manufacturer’s official labeling or instructions for use. Typically, dental adhesives like this require protection from extreme temperatures, moisture, and direct light, but confirmation of these details should be obtained directly from Zirkonzahn Srl to ensure proper preservation of the product’s efficacy.