Alpha-Bio Tec DFI
Also known as: DFI, Dual Fit Implant
A slightly tapered implant from Alpha-Bio Tec on the internal hex platform, with a double thread of variable depth and an apex carrying cutting flutes.
Quick facts
| Manufacturer | Alpha-Bio Tec. Ltd.Manufacturer-reported[1][2] |
|---|---|
| Body geometry | Slightly tapered bodyManufacturer-reported[1] |
| Thread design | Double thread design with variable threadsManufacturer-reported[1] |
| Apex design | Apex with cutting flutesManufacturer-reported[1] |
| Material | Titanium alloy Ti-6Al-4V ELIManufacturer-reported[1] |
| Surface | NanoTec — sandblasting with 20–40 micron particles followed by a double thermal etchManufacturer-reported[1] |
| Connection | Internal hexManufacturer-reported[1] |
| Platform switching | Manufacturer documentation not located |
| Available diameters | Ø3.3, 3.75, 4.2 and 5.0 mmManufacturer-reported[1] |
| Available lengths | 8, 10, 11.5 and 13 mmManufacturer-reported[1] |
Overview
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
| Geographic availability | Requires manual verification |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Alpha-Bio Tec DFI. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Alpha-Bio Tec at brand level and cover its implant range, not Alpha-Bio Tec DFI 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) clearance1 record
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K063364 | ALPHA BIO DENTAL IMPLANT SYSTEM | Alpha-Bio Tec , Ltd. | 2007-03-14 |
Clearance records for Alpha-Bio Tec 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 Alpha-Bio Tec.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Alpha-Bio Tec Product Catalog 2019 — Alpha-Bio Tec. Ltd., 2019. Accessed 2026-07-21.
- [2]Part of Envista Group — Alpha-Bio Tec. — Alpha-Bio Tec. Ltd.. Accessed 2026-07-21.