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Neodent Titamax GM

Also known as: Titamax Grand Morse, Titamax GM

A cylindrical, parallel-walled bone-level implant from Neodent on the Grand Morse connection, presented for dense bone and grafted sites.

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Quick facts

ManufacturerNeodent (JJGC Indústria e Comércio de Materiais Dentários S.A.), part of the Straumann GroupManufacturer-reported[1]
Implant levelBone level; Neodent instructs placement 1–2 mm below bone levelManufacturer-reported[1]
Body geometryCylindrical implant with parallel wallsManufacturer-reported[1]
Thread designV-shaped threads on a double threadManufacturer-reported[1]
Apex designSelf-tapping apex; Neodent states no bone tap or contour drill is requiredManufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceOffered on two surfaces: NeoPoros, a blasted and acid-etched surface with a reported roughness of Sa 1.4–1.8 µm, and Acqua, the hydrophilic version of the same surfaceManufacturer-reported[1][2]
ConnectionGrand Morse — a deep 16-degree Morse taper with an internal index, a Ø3.0 mm socket and platform switching; the same connection is used on every Grand Morse implant regardless of diameterManufacturer-reported[1]
Platform switchingPlatform switching is built into the Grand Morse connectionManufacturer-reported[1]
Available diametersØ3.5, 3.75, 4.0 and 5.0 mmManufacturer-reported[1]
Available lengths7, 8, 9, 11, 13, 15 and 17 mm from Ø3.5 to Ø4.0; Ø5.0 in 7, 8, 9, 11 and 13 mmManufacturer-reported[1]

Overview

Titamax is the parallel-walled member of the Grand Morse family, and it exists for the opposite problem to Drive: dense bone, where a tapered implant can generate more compression than is useful and where vertical position needs to be adjustable during placement. Its length range extends further than the other two Grand Morse implants, reaching 17 mm at the narrower diameters. The connection, the surfaces and the prosthetic components are shared with Helix and Drive.

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 for bone types I and II and for grafted areas such as bone blocksManufacturer-reported

Further detail

Immediate protocolMaximum placement torque 60 Ncm, insertion speed 30 rpmManufacturer-reported[1]
Geographic availabilityRequires manual verification

Clinical evidence

We have not yet completed a system-specific evidence review for Neodent Titamax GM. Insufficient system-specific evidence How we grade evidence

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Popular comparisons

The clearances below are held by Straumann at brand level and cover its implant range, not Neodent Titamax GM 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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