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Espe GmbH (US)

Country not established

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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  • Modified Visio-Seal Ref K873069

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

  • Chelon-Fil Ref K884475

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

  • Pertac Bond Ref K900558

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

  • Permadyne Adhesive Ref K875228

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

  • Impression Material, Alginate Ref K770872

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

  • Espe Tulux-Cem Ref K891020

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

  • Photac-Bond Aplicap, Modification Ref K915005

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

  • Permagum Ref K771627

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

  • Visio-Opaquer Ref K822453

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

Showing 51-59 of 59