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Neodent GM Zygoma-S

Also known as: GM Zygoma-S, Zygoma-S, Neodent Zygoma GM

A zygomatic implant from Neodent that carries the Grand Morse connection, anchoring in the zygomatic bone when the posterior maxilla has resorbed beyond conventional implant placement.

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Quick facts

ManufacturerNeodent (JJGC Indústria e Comércio de Materiais Dentários S.A.), part of the Straumann GroupManufacturer-reported[1]
Body geometryBody diameter of 3.5 mm or 3.75 mm with a coronal portion of 4.3 mm diameterManufacturer-reported[1]
MaterialManufacturer documentation not located
SurfaceSmooth machined surface along the implant body, with the apex carrying the NeoPoros surface for anchorage in the zygomaManufacturer-reported[1]
ConnectionGrand Morse — the same 16-degree deep Morse taper with platform switching used across the Grand Morse line, one connection regardless of implant diameterManufacturer-reported[1][2]
Platform switchingPlatform switching is part of the Grand Morse connectionManufacturer-reported[1]
Available diameters3.5 mm and 3.75 mmManufacturer-reported[1]
Available lengthsTen lengths: 30, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5 and 55 mmManufacturer-reported[1]

Overview

Zygomatic implants are a different proposition from conventional ones: they are long enough to pass from the alveolar region into the zygomatic bone, which is why the lengths run from 30 mm to 55 mm rather than 8 mm to 15 mm. Neodent’s version carries the same Grand Morse connection as the rest of the line, so the prosthetic components are shared, though the steep angulations required in the atrophic maxilla mean specific angled abutments are reserved for the zygomatic implants. Much of the body is deliberately left machined rather than roughened, on the reasoning that the mid-portion of the implant may be exposed to sinus or soft tissue rather than bone. Zygomatic placement is a surgically demanding procedure with its own complication profile and is not an alternative to a routine implant.

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.

Presented for immediate fixed treatment protocols in the severely atrophic maxillaManufacturer-reported

Further detail

Prosthetic ecosystemStraight and angled abutment options, with Mini Conical abutments at angles including 45 and 60 degrees indicated for use only with Zygoma GM and Zygoma-SManufacturer-reported[1]
Geographic availabilityRequires manual verification

Clinical evidence

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

Similar implant systems

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