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Espe Dental AG

GermanyFDA applicant, unverified

Devices
29

What Espe Dental AG makes

Espe Dental AG manufactures dental materials and equipment, including impression materials like Impregum Penta and Dimension, dental cements such as Ketac Cem U and Procem, and casting investments like Vitron M and Vestogum. The company also produces dental hardware and accessories, including the Pentamix 2 mixing unit, the Elipar Trilight curing light, and the L-Pop delivery system.

The company is based in the US, and its portfolio consists of Class I and Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 28 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue29

Newest first, rows 1-29 of 29

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  • Hytac Ref K992909

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

  • Impregum Penta M Monosoft Ref K994192

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

  • Pentamix 2 Ref K991913

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

  • Vitron M Ref K990763

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

  • Vestogum Ref K991221

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

  • Ketac Cem U Ref K002793

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

  • Modification To Prompt L-Pop Ref K001494

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

  • Dimension Bite Ref K991008

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

  • Procem Ref K984248

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

  • Elipar Trilight Ref K984247

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

  • Dimension Garant L, Dimension Garant L Quick Ref K000588

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

  • Impregum Penta Ref K992897

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

  • Sinfony Ref K992645

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

  • Vitron H Ref K991220

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

  • Impregum Garant L Duosoft Ref K994190

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

  • Elipar Freelight Ref K011154

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

  • Cavit Lc Ref K990982

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

  • Prompt L-Pop Ref K984246

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

  • Protemp H Ref K002364

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

  • Promptflow Ref K993566

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

  • Impregum Penta Duosoft Ref K994193

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

  • Impregum F Ref K992895

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

  • Dimension Penta L Ref K000595

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

  • Everbond Ref K983414

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

  • Reference Ref K992966

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

  • Lava Frame, Lava Frame Shade, Lava Ceram Ref K011394

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

  • Ketac-Molar Quick Ref K994251

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

  • Modification Of Prompt L-Pop Ref K992048 Open recall

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

  • Dimension Penta H, Dimension Penta H Quick Ref K000591

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

Rows 1-29 of 29

Frequently asked questions

How many devices does Espe Dental AG have in the registry?

The registry currently lists 29 devices for Espe Dental AG. Devices recorded under merged duplicate company entries are counted once.

Which registries list Espe Dental AG's devices?

Among its 29 most recently registered devices, Espe Dental AG has devices listed in FDA 510(k) (29 devices).

What risk classes do Espe Dental AG's devices fall under?

Among its 29 most recently registered devices, the classes recorded for Espe Dental AG's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Espe Dental AG in the registry?

The most recently registered devices listed for Espe Dental AG include HYTAC, IMPREGUM PENTA M MONOSOFT, PENTAMIX 2 and VITRON M.

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