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DIO

Also known as: DIO Implant, UF, UV Active, DIOnavi

The implant brand of DIO Corporation of South Korea, covering the UF(II) and UV Active fixtures and the DIOnavi guided workflow.

Key facts

ManufacturerDIO CorporationVerified spec[1]
CountrySouth KoreaVerified spec[1]
SurfaceSLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titaniumVerified spec[1][2]
ConnectionInternal connection with a Morse taperVerified spec[2]
manufacturingCountrySouth KoreaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

DIO’s implants trade under the UF(II) and UV Active names, both grade-4 titanium fixtures with an SLA surface and an internal Morse-taper connection. The brand is most associated internationally with DIOnavi, a fully guided digital surgery and denture system, so "DIO" on a treatment plan often signals a digital workflow rather than a particular fixture. DIO Corporation is listed on the Korean KOSDAQ exchange.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance2 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K182194UV Active Implant SystemDio Corporation2018-12-14
K070570DIO IMPLANT SYSTEMDio Department Dsi, Inc.2008-04-15

Other1 record

Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

NumberDeviceHolderDate
3007126709DIO Corporation

Clearance records for DIO were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to DIO.

Sources

Numbers match the citations beside each claim above.

Primary sources

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