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Espe GmbH & Co. KG.

GermanyFDA applicant, unverified

Devices
17

What Espe GmbH & Co. KG. makes

Espe GmbH & Co. Kg. manufactures dental adhesives, composites, and restorative materials, including polyvinyl siloxane impression materials, resin-based composites (e.g., SINFONY series), bonding agents (e.g., EBS), and temporary filling systems (e.g., PROTEMP GARANT). Their portfolio also includes dental cements (e.g., KETAC-FIL), application tips for composites, and specialized tools like the COJET system for surface treatment.

The company’s devices are classified as Class II under FDA regulations and are listed via 510(k) clearance. Their products are intended for dental use in the United States, where the manufacturer is based.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue17

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  • Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive Ref K960547

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

  • Cojet System Ref K963735

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

  • Permadyne Garant 2:1 Ref K953374

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

  • Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal, Sinfony Magic Modifiers, Sinfony Opaquer Ref K973513

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

  • Microgliss Ref K954180

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

  • Ebs (Espe Bonding System) Ref K962428

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

  • Hytac Aplitip/Hytac Osb Ref K962442

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

  • Protemp(R) Garant Ref K950203

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

  • Ketac-Fil Aplicap Plus Ref K973262

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

  • Ramitec Penta Ref K952693

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

  • Hycem Aplicap Ref K963737

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

  • Position Penta, Position Penta Quick Ref K974231

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

  • Pertac Ii/Pertac Ii Aplitip Ref K962440

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

  • Permadyne Penta (High & Low Viscosity) Ref K953027

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

  • Ketac-Molar Aplicap Ref K960954

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

  • Impregum Penta Ref K954192

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

  • Cavit-Lc Ref K972892

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

Rows 1-17 of 17

Frequently asked questions

How many devices does Espe GmbH & Co. Kg. have in the registry?

The registry currently lists 17 devices for Espe GmbH & Co. Kg.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Espe GmbH & Co. Kg.'s devices?

Among its 17 most recently registered devices, Espe GmbH & Co. Kg. has devices listed in FDA 510(k) (17 devices).

What risk classes do Espe GmbH & Co. Kg.'s devices fall under?

Among its 17 most recently registered devices, the classes recorded for Espe GmbH & Co. Kg.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Espe GmbH & Co. Kg. in the registry?

The most recently registered devices listed for Espe GmbH & Co. Kg. include DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE, COJET SYSTEM, PERMADYNE GARANT 2:1 and SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL, SINFONY MAGIC MODIFIERS, SINFONY OPAQUER.

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