DIO UF(II) Implant System
Also known as: UF(II), UF II, DIO UF
A tapered bone-level implant from DIO with an internal Morse-taper connection and an SLA surface.
Quick facts
| Manufacturer | DIO CorporationVerified spec[1] |
|---|---|
| Implant level | Bone-levelVerified spec[1] |
| Body geometry | Tapered (root-form) fixtureVerified spec[1] |
| Material | Grade-4 commercially pure titanium (ASTM F67)Verified spec[1] |
| Surface | SLA — sandblasted with large grit and acid-etchedVerified spec[1] |
| Connection | Internal connection with a Morse taperVerified spec[2] |
| Available diameters | Ø3.8, 4.0, 4.5, 5.0 and 5.5 mmVerified spec[1] |
| Available lengths | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0 and 16.0 mm (the 7.0 mm length is not offered at Ø3.8 or 4.0 mm)Verified spec[1] |
Overview
Technology
Clinical positioning
What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for DIO UF(II) Implant System. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by DIO at brand level and cover its implant range, not DIO UF(II) Implant System specifically. We show them here because that is the level at which regulators actually issue them.
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.
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.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3007126709 | — | DIO 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
- [1]FDA 510(k) K170608 — UF(II) Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.
- [2]FDA 510(k) K182194 — UV Active Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.