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Innobiosurg Co., Ltd.

Country not established FDA

Devices
15
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Innobiosurg Co., Ltd. makes

Innobiosurg Co., Ltd. manufactures dental implant systems, including premilled titanium blocks and implant components for surgical placement. Their portfolio includes modular implant systems like the IBS Implant System and Magicore variants, designed for dental reconstruction. These products are intended for use in oral and maxillofacial applications, supporting fixed or removable prosthetics.

The company’s dental implant systems are classified as Class II devices under FDA regulations and are authorised through the 510(k) clearance pathway. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue15

Newest first, rows 1-15 of 15

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  • IBS Implant System II Ref K162099

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

  • Premilled Titanium Block System Ref K203344

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

  • IBS Implant System Ref K202479

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

  • IBS Implant System II Ref K200753

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

  • Magicore II System Ref K201621

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

  • Ibs Implant System Ref K140806

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

  • IBS System Ref K220517

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

  • Magicore System Ref K201981

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

  • Magicore System Ref K152520

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

  • Magicore Narrow System Ref K220079

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

  • IBS Implant System Ref K153350

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

  • Magicore System Ref K212517

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

  • Magic UCLA Abutment System Ref K202418

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

  • CCM Abutment System Ref K173120

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

  • Magicore II System Ref K192197

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

Rows 1-15 of 15

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Innobiosurg Co., Ltd. Daejeon · KR FEI 3008309654

Frequently asked questions

How many devices does Innobiosurg Co., Ltd. have in the registry?

The registry currently lists 15 devices for Innobiosurg Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Innobiosurg Co., Ltd.'s devices?

Among its 15 most recently registered devices, Innobiosurg Co., Ltd. has devices listed in FDA 510(k) (15 devices).

What risk classes do Innobiosurg Co., Ltd.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Innobiosurg Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Innobiosurg Co., Ltd. in the registry?

The most recently registered devices listed for Innobiosurg Co., Ltd. include IBS Implant System II, Premilled Titanium Block System, IBS Implant System and Magicore II System.

Which FDA establishments are linked to Innobiosurg Co., Ltd.?

1 FDA establishment is linked to Innobiosurg Co., Ltd. in the registry; they are listed on the company page.

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