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Alpha-Bio Tec Spiral (SPI)

Also known as: SPI, Spiral, Alpha-Bio SPI, Spiral Implant

A self-drilling, bone-condensing implant from Alpha-Bio Tec on the internal hex platform, listed in current catalogues as Spiral and formerly named SPI.

Quick facts

ManufacturerAlpha-Bio Tec. Ltd.Manufacturer-reported[1][2]
Body geometryOsteotome-like condensing body with a pronounced tapered coreManufacturer-reported[1]
Thread designSharp, deep threads in the apical part; Alpha-Bio describes the implant as self-drillingManufacturer-reported[1]
Apex designApical part with sharp deep threadsManufacturer-reported[1]
MaterialTitanium alloy Ti-6Al-4V ELIManufacturer-reported[1]
SurfaceNanoTec — sandblasting with 20–40 micron particles followed by a double thermal etchManufacturer-reported[1]
ConnectionInternal hexManufacturer-reported[1]
Platform switchingManufacturer documentation not located
Available diametersØ3.3, 3.75, 4.2, 5.0 and 6.0 mmManufacturer-reported[1]
Available lengths8, 10, 11.5, 13 and 16 mm; Ø6.0 is not listed at 16 mmManufacturer-reported[1]

Overview

The naming here causes real confusion: Alpha-Bio’s 2019 catalogue lists this implant as “Spiral” and footnotes it as formerly known as SPI, so older records, laboratory libraries and second-hand accounts may use either name for the same implant. Its design intent is bone condensation — a pronounced tapered core and sharp apical threads that let it be driven into soft bone with little or no drilling, and that allow its path to be redirected during insertion. It sits on the internal hex platform, not the conical one, so it does not share components with the conical NeO variants.

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.

Indicated by Alpha-Bio for bone types III and IVManufacturer-reported

Further detail

Predecessor systemAlpha-Bio’s 2019 catalogue footnotes the Spiral implant as “formerly known as SPI”Manufacturer-reported[1]
Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for Alpha-Bio Tec Spiral (SPI). Insufficient system-specific evidence How we grade evidence

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Popular comparisons

The clearances below are held by Alpha-Bio Tec at brand level and cover its implant range, not Alpha-Bio Tec Spiral (SPI) 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.

NumberDeviceHolderDate
K063364ALPHA BIO DENTAL IMPLANT SYSTEMAlpha-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

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