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Columbus Dental Mfg. Co.

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Devices
11

What Columbus Dental Mfg. Co. makes

Columbus Dental Mfg. Co. produces dental utility products, including flavored wax strips (cinnamon and spearmint), orthodontic wax wafers, and rubber dam materials for isolation during procedures. Their portfolio also encompasses dental adhesives like the Gluma Bonding System and light-cured composite restorative systems, such as Pekalux and Pekalux/Gluma. Additional offerings include dental cleaning solutions (e.g., Dri-Clave Liquid Kleenzall) and dental gels (e.g., Shur Gel and Shur Gel 4).

The company’s products are regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. These items are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device regulations. The manufacturer is based in the United States.

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

Catalogue11

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  • Utility Wax Strips, Cinnamon Ref K880606

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

  • Lumifor(Tm) Composite Ref K871165

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

  • Gluma(Tm) Bonding System Ref K871164

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

  • Pekalux/Gluma Light Cured Anterior Restorative Sys Ref K872272

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

  • Shur Gel Ref K830083

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

  • Ortho-Bite Wax Wafer Ref K863758

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

  • Pekalux(Tm) Ref K872243

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

  • Shur Gel 4 Ref K860855

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

  • Dri-Clave Liquid Kleenzall Ref K880754

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

  • Ivory Premium Rubber Dam Ref K863816

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

  • Utility Wax Strips, Spearmint Ref K880607

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

Rows 1-11 of 11

Frequently asked questions

How many devices does Columbus Dental Mfg. Co. have in the registry?

The registry currently lists 11 devices for Columbus Dental Mfg. Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Columbus Dental Mfg. Co.'s devices?

Among its 11 most recently registered devices, Columbus Dental Mfg. Co. has devices listed in FDA 510(k) (11 devices).

What risk classes do Columbus Dental Mfg. Co.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Columbus Dental Mfg. Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Columbus Dental Mfg. Co. in the registry?

The most recently registered devices listed for Columbus Dental Mfg. Co. include UTILITY WAX STRIPS, CINNAMON, LUMIFOR(TM) COMPOSITE, GLUMA(TM) BONDING SYSTEM and PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS.

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