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Espe GmbH (US)

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Devices
59

What Espe GmbH (US) makes

Espe GmbH manufactures dental adhesives, temporary cements, and radiopaque restorative materials, including bonding agents like PALGAFLEX and PHOTAC-BOND, as well as low-viscosity dental sealants such as PERMADYNE GARANT. Their portfolio also includes composite resin systems like VISIO-GEM ART-SYSTEM and radiopaque cement formulations like ESPE KETAC-CEM RADIOPAQUE, alongside cavity liners and temporary filling materials such as CAVIT-W and ESPETEMP.

The company’s products are classified under FDA’s Class I and Class II categories, with relevant devices listed under the 510(k) pathway. These dental materials are intended for use in restorative and adhesive procedures, adhering to U.S. regulatory requirements for medical devices.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue59

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  • Palgaflex And Palgaflex-Quick Ref K884381

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Permagum Adhesive Ref K771853

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Photac-Bond Ref K904096

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rocatec(R) -Plus Ref K913857

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visio-Perl Ref K882566

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Ketac-Cem Radiopaque Ref K844846

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espetemp (Temp. Cement) Ref K770923

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cavit-W Ref K875133

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Permadyne Garant Low Viscosity Ref K896539

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visio-Gem Art-System Ref K905604

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Capmix Ref K891064

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Espe Chelon-Silver Ref K865028

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Ketac-Bond Ref K844845

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nimetic Polishing Paste Ref K771852

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Uviobond Ref K771328

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modified Permagum Adhesive Ref K881838

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nimetic Bonding Material Ref K771326

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe(R) -Sil Ref K913965

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Applic System Activator, Espe Ref K770941

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ketac-Silver Ref K843566

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Polyether-Retarder Ref K892412

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sono(R) -Cem Ref K913966

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Photac-Fil Aplicap Ref K925027

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ketac-Bond Aplicap Ref K874788

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tulux-Filter Ref K892517

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Nimeticap Ref K771654

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pertac Universal Bond Ref K904289

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Protemp Ref K822452

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Nimetic-Grip Ref K844844

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ketac Applic-Capsules Ref K790832

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Dental Restorative In Capsules Ref K770922

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visio-Bond Ref K790833

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ketac-Glaze Ref K884752

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Varnish Ref K880741

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Impregum F Adhesive Ref K875257

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Nimetic Etching Gel Ref K771325

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Applic System Applier, Espe Ref K770931

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Visio-Dispers Ref K790823

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Impregum-F Ref K853529

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Alkaliner Ref K873882

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Protemp Ii Ref K900436

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Uviofil Ref K771327

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ketac-Conditioner Ref K872984

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Ketac-Cem Maxicap Ref K897188

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visio-Fil Ref K812169

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Pertac-Hybrid Ref K900510

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Visio-Gem Ref K833757

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Espe Visio-Molar Ref K862292

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Palgarapid Ref K892839

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Photac-Bond Aplicap Ref K904097

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 59

Showing 1-50 of 59

Frequently asked questions

How many devices does Espe GmbH (Us) have in the registry?

The registry currently lists 59 devices for Espe GmbH (Us). Devices recorded under merged duplicate company entries are counted once.

Which registries list Espe GmbH (Us)'s devices?

Among its 50 most recently registered devices, Espe GmbH (Us) has devices listed in FDA 510(k) (50 devices).

What risk classes do Espe GmbH (Us)'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Espe GmbH (Us)'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Espe GmbH (Us) in the registry?

The most recently registered devices listed for Espe GmbH (Us) include PALGAFLEX AND PALGAFLEX-QUICK, PERMAGUM ADHESIVE, PHOTAC-BOND and ROCATEC(R) -PLUS.

Generated automatically from registry data and not verified by a human reviewer.