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Straumann TLX

Also known as: TLX, Straumann TLX Implant System

A fully tapered tissue-level implant system from Straumann, made in Roxolid and using the TorcFit connection, offered with either a 1.8 mm or a 2.8 mm transmucosal neck.

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Quick facts

Current statusCurrent. Straumann publishes a TLX Basic Information document revised November 2024.Manufacturer-reported[1]
Implant levelTissue level. Straumann states that the TLX Implant System offers fully tapered tissue level implants.Manufacturer-reported[1]
Body geometryFully tapered body with a transmucosal neck of either 1.8 mm (Standard Plus, SP) or 2.8 mm (Standard, S).Manufacturer-reported[1]
Thread designManufacturer documentation not located(The TLX Basic Information document reviewed here does not state a thread pitch specification.)
Apex designManufacturer documentation not located
MaterialRoxolid — Straumann’s titanium-zirconium alloy.Manufacturer-reported[1][2]
SurfaceOffered with either the SLActive or the SLA surface.Manufacturer-reported[1]
ConnectionTorcFit. Prosthetic components are designated NT (Narrow TorcFit), RT (Regular TorcFit) and WT (Wide TorcFit), corresponding to implant shoulder diameters of ∅ 3.5, 4.8 and 6.5 mm respectively.Manufacturer-reported[1]
Platform switchingManufacturer documentation not located(As a tissue-level implant the prosthetic interface sits at the implant shoulder above bone; the documentation reviewed makes no platform-switching claim.)
Available diametersMaximum endosteal outer diameter ∅ 3.75, 4.5, 5.5 and 6.5 mm.Manufacturer-reported[1]
Available lengths6–18 mm for ∅ 3.75 mm and ∅ 4.5 mm; 6–12 mm for ∅ 5.5 mm and ∅ 6.5 mm. Both neck heights are offered across the same length range.Manufacturer-reported[1]

Overview

TLX is Straumann’s attempt to bring the immediacy-focused design of BLX to a tissue-level implant, and the two share the TorcFit connection. The defining feature of a tissue-level implant is that the junction between implant and abutment sits above the bone rather than at it, which moves the microgap away from the crest; TLX preserves that while adding a fully tapered body. Buyers should note the two neck heights — 1.8 mm (Standard Plus) and 2.8 mm (Standard) — because the choice is made at surgery and determines how much of the polished collar sits through the gum. TLX is not a replacement for the older synOcta-based tissue-level implants; those use a different connection entirely, so components do not cross over.

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.

Straumann describes TLX as designed for high primary stability and immediate treatment procedures.Manufacturer-reported

Clinical evidence

We have not yet completed a system-specific evidence review for Straumann TLX. Insufficient system-specific evidence How we grade evidence

Similar implant systems

Popular comparisons

The clearances below are held by Straumann at brand level and cover its implant range, not Straumann TLX 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) clearance30 records

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

NumberDeviceHolderDate
K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG2026-03-10
K250294Straumann® RidgeFit ImplantsInstitut Straumann AG2025-08-12
K241391Straumann® PURE Ceramic ImplantsInstitut Straumann AG2024-12-10
K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG2024-03-20
K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG2023-09-14
K223083Straumann SLActive labeling changesInstitut Straumann AG2023-06-22
K211052Straumann RidgeFit ImplantsInstitut Straumann AG2021-07-08
K210855Straumann BLX Implant SystemInstitut Straumann AG2021-06-21
K202942Straumann 4 mm Short ImplantsStraumann USA, LLC2021-02-08
K200586Straumann TLX Implant SystemInstitut Straumann AG2020-08-20
K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG2019-12-27
K191895Straumann Mini ImplantsInstitut Straumann AG2019-12-09
K190662MRI Compatibility for Existing Straumann Dental Implant SystemsStraumann USA, LLC2019-06-17
K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG2019-01-04
K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG2018-12-28
K173961Straumann BLX Implant SystemInstitut Straumann AG2018-06-05
K171784Straumann Dental Implant SystemStraumann USA, LLC2018-01-19
K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag)2017-11-14
K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG2016-03-23
K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC2015-07-24
K140878STRAUMANN BONE LEVEL TAPERED IMPLANTStraumann USA, LLC2014-08-20
K130222STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA, LLC2013-04-29
K123784STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA, LLC2013-04-10
K111357STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEMStraumann USA2011-10-03
K093027STRAUMANN RC TEMPORARY ABUTMENTSStraumann USA2010-02-12
K083550STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA2009-02-26
K081419STRAUMANN DENTAL IMPLANT SYSTEMInstitut Straumann AG2009-02-20
K060958STRAUMANN NARROW NECK IMPLANTSStraumann USA2006-08-24
K061176STRAUMANN DENTAL IMPLANTSInstitut Straumann AG2006-08-11
K033984STRAUMANN DENTAL IMPLANT SYSTEMInstitut Straumann AG2004-06-30

Other1 record

Of 100 records we inspected, 93 are supplied sterile, 7 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (52); MR Conditional (48). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.

NumberDeviceHolderDate
1219 device records—Straumann—

Clearance records for Straumann 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 Straumann.

Sources

Numbers match the citations beside each claim above.

Primary sources

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