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Union Broach, Div. Moyco Industries, Inc.

United StatesFDA applicant, unverified

Devices
14

What Union Broach, Div. Moyco Industries, Inc. makes

Union Broach, a division of Moyco Industries, Inc., manufactures dental instruments and materials primarily for endodontic and restorative procedures. Their portfolio includes nickel-titanium and stainless steel root canal files, barbed broaches, and flexible endodontic tips designed for cleaning and shaping root canals. They also produce dental bleaching lights, thermal pulp testers, and edetic acid solutions for root canal treatment, alongside filtration systems like the Quadrasorb filter. Additionally, they supply dental cements and kits, such as the Cyber-Fil alkenoate cement, for multi-purpose use in dental restorations.

The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U) devices, with many authorised through the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device regulations. Union Broach operates as part of Moyco Industries, Inc., based in the United States.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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  • Inject-R Fill Ref K931742

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

  • Nickel-Titanium K-Type File Ref K935542

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

  • Union Broach Bleaching Light Ref K895174

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

  • Thermal Pulp Tester Ref K940260

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

  • Moyco-Edta Ref K950365

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

  • Root Canal Files, Type K Ref K822621

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

  • Quadrasorb Filter Ref K923661

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

  • Flexor Flexible Roane Tip Endodontic File Ref K855136

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

  • Retro Mirror Ref K941574

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

  • Endodontic Broach-Barbed Broach Ref K823489

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

  • Cyber-Fil Alkenoate Cement Multi-Purpose Kit (23900/23905/23910/23915/23920) Ref K962733

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

  • Union Broach Bleaching Light Ref K852474

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

  • Root Canal Files, Type H (Hedstrom Ref K822622

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

  • Root Canal Reamers, Type K Ref K822620

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

Rows 1-14 of 14

Frequently asked questions

How many devices does Union Broach, Div. Moyco Industries, Inc. have in the registry?

The registry currently lists 14 devices for Union Broach, Div. Moyco Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Union Broach, Div. Moyco Industries, Inc.'s devices?

Among its 14 most recently registered devices, Union Broach, Div. Moyco Industries, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Union Broach, Div. Moyco Industries, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Union Broach, Div. Moyco Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Union Broach, Div. Moyco Industries, Inc. in the registry?

The most recently registered devices listed for Union Broach, Div. Moyco Industries, Inc. include INJECT-R FILL, NICKEL-TITANIUM K-TYPE FILE, UNION BROACH BLEACHING LIGHT and THERMAL PULP TESTER.

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