CleanImplant - implants

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CleanImplant "Trusted Quality" Mark

Implant systems that comply with the CleanImplant Quality Mark Criteria according to the consensus recommendation of the Scientific Advisory Board are listed below. This guideline for clean implants was released September 2017 and has yet been established in many implant manufactoring sites as de-facto standard for the cleanliness of implantable devices.

Click on the Quality Mark image to download the consensus paper (4 MByte PDF-file).

For the comprehensive quality assessment five implant samples of each implant type have been analyzed by means of SEM and elemental analysis. The certification "Trusted Quality" is valid for two years before the CleanImplant re-evaluation process has to start. Hence, the list of implant systems (in alphabetic order) carrying the "Trusted Quality Mark" is continually updated and extended.

The implant system of your choice is not listed below ? Please do not hesitate and send us a mail !

"Trusted Quality" Implant Types 2023 (in alphabetic order)

ASTRA TECH EV - Dentsply Sirona

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Biotech Dental – Kontact S

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bredent medical – whiteSKY

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BTI Biotechnology Institute - UnicCa

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Champions Implants - R(E)volution

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Dentis - s-Clean SQ-SL

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Dentium – SuperLine

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Global D – In-Kone

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Medentis Medical – ICX-Premium - Re-evaluation currently in peer-review

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MegaGen – Anyridge

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MegaGen - BlueDiamond

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NucleOSS – T6

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Ritter Implants - Spiral SB/LA

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Southern Implants - INVERTA

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Swiss Dental Solutions - SDS2.2

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Swiss Dental Solutions - SDS1.2

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NOTE:

More implant types were analyzed in the framework of the "CleanImplant Trusted Quality Mark". Quality assessments of these implants and the peer-review processes are pending.

CleanImplant Quality Assessment Study Study 2021-2022

A wide range of implant samples from recent production are currently collected by the research team of the CleanImplant Foundation. The selection of implant systems was made by the Scientitic Advisory Board of the Foundation. If, beyond this, manufacturers wish to include their implant system and become a passive or active participant, they are asked to fill out this form.

SEM results and images of the Implant Study 2017-2020

More than 100 implant types from manufacturers from over 20 countries were analyzed by the CleanImplant Foundation following the accredited and thorough protocol of analysis according to DIN EN ISO/IEC 17025. Results will be published in scientific peer-reviewed journals soon. Certified Dentists and Fellow Members can apply for preliminary results of analysis about implants they have in use. Find out more here

SEM results and images of the Implant Study 2014-2015

To avoid misuse of these data by competitors CleanImplant Foundation sticks to the statutes and does not publish sensitive data here.

The full report based on the Implant Study 2014-2015 (released April 2016) with 822 pages and 2.950 SEM images of 135 different implants (95 brands) including 150 qualitative and quantitative elemental analyses can be requested at info@cleanimplant.com . (PDF or printed version).

Important note:

Below you can find different examples of inorganic and organic implant pollution.

We do not intend to publish the name of the implant manufacturer(s) or type of these analyzed implants for three reasons:

First of all some implant companies already tried to threaten us with steps of legal action after we informed them about the scientific results of single sample SEM / EDX analysis.

Second we prefer to concentrate our energy and resources into building a stage for companies who care for their quality and for products that deserve our trust.

And last but not least it is not our intention to stigmatize specific manufacturers as there is always a chance for improvement in the manufacturing of dental implants.

Examples of Implant Residues

Single organic particles (1-5 particles) were found on many implants. Clinical effects of these isolated particles can be considered as negligible.

However, a significant number of implants showed a systematic distribution pattern of organic particles i.e. mainly on the outer threads of the implant or on the shoulder area. In the material contrast SEM images these particles appear dark in comparison to titanium or zirconium (see below).

Massive organic pollution on titanium implants (above).

A zironium made implant showed indentations of 20-100 µm filled with organic material (below).

Two samples showed traces of carbon and fluorine in the elemental spot analysis of fibres (5-50 µm). These fibres are probably remnants of polytetrafluoroethylene (PTFE) originating from teflon coated baskets used during the production process.

Significant signals of iron <Fe>, chromium <Cr> and nickel <Ni> in the elemental spot analysis of particles (20-50 µm) on this implant may be a hint for recycled or polluted blasting material containing particles of stainless steel (see below).

Some particles (1-5 µm) showed clear fingerprints of copper < Cu > and tin < Sn> in the elemental analysis as seen in the images below. These metal particles appear bright in the material contrast SEM image and are each embedded in larger organic contaminants (30-100 µm).

Surprisingly traces of antimony and tungsten were found in the EDX analysis of sterile packed implants.

Antimony < Sb > particles
(bright) embedded in organic pollution (dark)

Tungsten < W > particles (bright) probably originated from CNC-machining tools
embedded in organic matrix (dark)

Note: All text, SEM images and EDX data are copyright protected.

No part may be multiplied in any way whatsoever, neither by copying, print, microfilm, electronically or otherwise without prior permission in writing from the copyright holder, Dr. Dirk Duddeck, Berlin, Germany and/or CleanImplant Foundation CIF GmbH, Berlin, Germany.
Unauthorized copying or use of this website will be an infringement of the property rights.

"Trusted Quality" Implant Types 2023 (in alphabetic order)

Swiss Dental Solutions - SDS2.2

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