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DIMPLO, Ltd.

South KoreaFDA 510(k) applicant, unverified FDA

Devices
522
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What DIMPLO, Ltd. makes

DIMPLO, Ltd. manufactures the DIMPLO Implant System, a medical device designed for surgical implantation within the body.

The DIMPLO Implant System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) registry. The company is based in the United States.

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

Catalogue522

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Company details

DUNS number
963392194

FDA establishments1

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

  • DIMPLO Ltd. Yeonje-gu Busan · KR FEI 3042971970

Frequently asked questions

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

The registry currently lists 522 devices for DIMPLO, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list DIMPLO, Ltd.'s devices?

Among its 50 most recently registered devices, DIMPLO, Ltd. has devices listed in FDA GUDID (50 devices).

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

Among its 50 most recently registered devices, the classes recorded for DIMPLO, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for DIMPLO, Ltd. include DIMPLO Fixture DFM3011, DIMPLO Fixture DFM3010, DIMPLO Fixture DFM3008 and DIMPLO Fixture DFM3508.

Which FDA establishments are linked to DIMPLO, Ltd.?

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

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