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Unitek Corp.

United StatesFDA 510(k) applicant, unverified

Devices
23

What Unitek Corp. makes

Unitek Corp. manufactures dental instruments and materials, including debracketing tools, saliva ejectors, and adhesive-precoated orthodontic brackets. Their portfolio also includes visible light curing units for dental composites, disposable impression syringes, and root canal posts. Additional products cover impression materials like Alastik and Alastigard, as well as tools for bracket removal and cap removal.

The company’s devices are regulated under FDA Class I and Class II classifications, with most requiring 510(k) clearance. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

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

Catalogue23

Newest first, rows 1-23 of 23

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  • Debracketing Instrument Ref K924295

    Class I
    Active 510(k) 510(k) I

  • Tongue Holder/Saliva Ejector Ref K800210

    Class I
    Active 510(k) 510(k) I

  • Nonstaining Alastiks Ref K910288

    Class I
    Active 510(k) 510(k) I

  • Ortholux Visible Light Curing Unit Ref K880392

    Class II
    Active 510(k) 510(k) II

  • Transcend Series 6000 Debonding Instruments Ref K924645

    Class I
    Active 510(k) 510(k) I

  • Adhesive Precoated Brackets Ref K911271

    Class II
    Active 510(k) 510(k) II

  • Unitek Disposable Impression Syringe Ref K851386

    Class I
    Active 510(k) 510(k) I

  • Unitek Convertible Cap Remover Tool Ref K843742

    Class I
    Active 510(k) 510(k) I

  • Alastigard Ref K890529

    Class I
    Active 510(k) 510(k) I

  • X-704 Ref K832253

    Class II
    Active 510(k) 510(k) II

  • Root Canal Post Ref K802515

    Class I
    Active 510(k) 510(k) I

  • Unitek Palatal Bar Ref K812239

    Class I
    Active 510(k) 510(k) I

  • Metal-Lined Transcend Ceramic Bracket Ref K944286

    Class II
    Active 510(k) 510(k) II

  • Dominion Ref K831098

    Class II
    Active 510(k) 510(k) II

  • Alastik Ref K940165

    Class I
    Active 510(k) 510(k) I

  • Transbond Light Cured Orthodontic Adhesive Ref K880393

    Class II
    Active 510(k) 510(k) II

  • German Mini Dynalock Ref K923432

    Class I
    Active 510(k) 510(k) I

  • Concerto Ref K831097

    Class II
    Active 510(k) 510(k) II

  • Heated Gutta Percha Delivery System Ref K832654

    Class I
    Active 510(k) 510(k) I

  • Alastik Ns Ref K923999

    Class I
    Active 510(k) 510(k) I

  • Stroma Ii Ref K831096

    Class II
    Active 510(k) 510(k) II

  • Unitek Ceramic Bracket System Ref K861965

    Class II
    Active 510(k) 510(k) II

  • Alastik Ref K933501

    Class I
    Active 510(k) 510(k) I

Rows 1-23 of 23

Frequently asked questions

How many devices does Unitek Corp. have in the registry?

The registry currently lists 23 devices for Unitek Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Unitek Corp.'s devices?

Among its 23 most recently registered devices, Unitek Corp. has devices listed in FDA 510(k) (23 devices).

What risk classes do Unitek Corp.'s devices fall under?

Among its 23 most recently registered devices, the classes recorded for Unitek Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Unitek Corp. in the registry?

The most recently registered devices listed for Unitek Corp. include DEBRACKETING INSTRUMENT, TONGUE HOLDER/SALIVA EJECTOR, NONSTAINING ALASTIKS and ORTHOLUX VISIBLE LIGHT CURING UNIT.

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