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Espe-Premier Sales Co.

Country not established

Devices
10

What Espe-Premier Sales Co. makes

Espe-Premier Sales Co. manufactures dental and orthodontic materials, including etching gels for tooth preparation, polishing pastes for restorative surfaces, and adhesive sealants for bonding orthodontic brackets. Their portfolio also includes light sources for curing dental composites, dispersing agents for mixing materials, and chemical adhesives for dental restorations. The company supplies products used in cavity preparation, bracket bonding, and restorative procedures.

The company’s devices are regulated under FDA’s Class I and Class II classifications, with several authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue10

Newest first, rows 1-10 of 10

  • Etching Gel Ref K810266

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

  • Nimetic Polishing Paste Ref K812118

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

  • Visio-Band Ref K810265

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

  • Permagum Ref K812116

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

  • Visio-Seal Ref K811624

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

  • Permagum Adhesive Ref K812117

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

  • Nimetic-Dispers Ref K812119

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

  • Elipar Light Source Ref K803209

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

  • Ketac-Chem Ref K812115

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

  • Visio-Dispers Ref K803227

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

Frequently asked questions

How many devices does Espe-Premier Sales Co. have in the registry?

The registry currently lists 10 devices for Espe-Premier Sales Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Espe-Premier Sales Co.'s devices?

Among its 10 most recently registered devices, Espe-Premier Sales Co. has devices listed in FDA 510(k) (10 devices).

What risk classes do Espe-Premier Sales Co.'s devices fall under?

Among its 10 most recently registered devices, the classes recorded for Espe-Premier Sales Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Espe-Premier Sales Co. in the registry?

The most recently registered devices listed for Espe-Premier Sales Co. include ETCHING GEL, NIMETIC POLISHING PASTE, VISIO-BAND and PERMAGUM.

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