Clean Implant
/

the global quality campaign

 

Trusted Quality Mark

A five-step approach

Implants listed below comply with the CleanImplant Quality Mark Criteria 2017-2018 according to the consensus recommendation of the Scientific Advisory Board. 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 list of implants (in alphabetic order) with the "Trusted Quality Mark 2017-2018" is continually updated and extended.

 


 

 STEP 1

 

Neutral sampling of 5 implants 

3 implants are ordered ex factory + 2 implants of the same type are provided via mystery shopping from practices. 

 

STEP 2

 

Unpacking and scanning under clean room conditions 

All 5 collected samples are carefully unpacked, mounted and scanned in a clean room environment according Class 100 US Fed. 209, Class 5 DIN EN ISO 14644-1.

 

STEP 3

 

Externally audited process of analysis 

SEM imaging and elemental analysis (EDS) are performed according to DIN EN ISO/IEC 17025 accreditation process (competence of testing and calibration laboratories) with external audits and multi-annual re-assessments.

 

STEP 4

 

Full-size and high-resolution SEM images

A special FSHR SEM image - digitally composed of more than 360 single SEM images in a magnification of 500x - shows always the complete surface; i.e. no “cherry-picking” of  clean looking areas.

 

STEP 5

 

Peer-review process

Two members of the Scientific Advisory Board independently review the comprehensive report of analysis and sufficient clinical documentation or multi-annual PMCF studies (Post-Marketing Clinical Follow-Up) of the analyzed implant type showing survival rates of more than 95% for the device or device family.


"Trusted Quality" Implant Types 2019 (in alphabetic order)

Bredent Medical – blueSKY

Click on the images to enlarge.

BTI – UniCa Implant

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MegaGen – Anyridge
Click on the images to enlarge.
 MIS Implants Technologies – V3
Click on the images to enlarge.
Natural Dental Implants – Replicate
Click on the images to enlarge.
Nobel - NobelActive
NucleOSS – T6
Click on the images to enlarge.
Straumann - SLA 

NOTE: 

More implants applied for the "CleanImplant Trusted Quality Mark". Analyses of these implants and peer-review processes are pending. 

You are missing information about the implant system of your choice? 

You don´t have to wait until the results of your specific implant are published in scientific journals. As a Fellow Members of the CleanImplant Community you will receive the desired information for up to three implant systems and a personalized certififcate for your practice. Find out more information about the membership here.

If you want to be sure that your implant system also carries the Trusted Quality Mark, ask the sales representatives or correspondent manufacturer to join the global quality assessment project.  

CleanImplant Listed Implants 2019 (in alphabetic order)
Implant systems listed below participated in the Implant Study 2017-2019 conducted by the CleanImplant Foundation or applied separately for a testing report in 2019 after the study ended. The SEM/EDS analysis of implants in this "Listed" section is based on one implant sample. Implants are only listed if they technically meet the criteria for "clean" as stated in the CleanImplant Consensus Document (guideline released 09.2017). Testing is performed and results are confirmed by an officially accredited testing institute according to DIN EN ISO/IEC 17025. 
Note: Clinical documentation is no precondition for this Listing and was not checked. All images are copyright protected. 
Astra (Dentsply Implants) | Osseospeed

Astra (Dentsply Implants) | Osseospeed

DIN EN ISO/IEC 17025 report: .18-00002-006

Testing report issued: 2018-03-13

Tested implant production date: 2017-10

Tested implant valid date: 2022-10

Website of manufacturer: https://implants.dentsplysirona.com

Notes / Comments: Sample showed no significant contamination within the scope of the analysis. Titinium-oxide particles are remnants of the blasting process. Implant is "clean" according to the CleanImplant guideline (consensus document released 09.2017).

DTI Implant Systems | DTI SLA Implant

DTI Implant Systems | DTI SLA Implant

DIN EN ISO/IEC 17025 Report: 18-00002-085

Testing report issued: 2019-02-23

Tested implant production date: 2019-02-14

Tested implant valid date: 20124-02-14

Website of manufacturer: www.dtiimplant.com

Notes / Comments: Sample showed no significant contamination within the scope of the analysis. Aluminum-oxide particles are remnants of the blasting process. Implant is "clean" according to the CleanImplant guideline (consensus document released 09.2017).

GC | Aadva

GC | Aadva

DIN EN ISO/IEC 17025 report: 18-00002-093

Testing report issued: 2019-03-27

Tested implant production date: 2018-02

Tested implant valid date: 2023-02

Website of manufacturer: https://www.gctech.eu

Notes / Comments: Sample showed no significant contamination within the scope of the analysis. Implant is "clean" according to the CleanImplant guideline (consensus document released 09.2017).

Medical Instinct | bonetrust

Medical Instinct | bonetrust

DIN EN ISO/IEC 17025 report: 18-00002-017

Testing report issued: 2018.04.10

Tested implant production date: 2017-08

Tested implant valid date: 2022-08

Website of manufacturer: https://www.medical-instinct.de/implantologie/bonetrust-implantatsysteme/

Notes / Comments: Sample showed no significant contamination within the scope of the analysis. Implant is "clean" according to the CleanImplant guideline (consensus document released 09.2017).

SEM results and images of the Implant Study 2017-2019 

We analyzed already numerous implant types from manufacturers of more than 20 countries and recent production following our accredited and thorough protocol of analysis according to DIN EN ISO/IEC 17025. Results will be published in scientific peer-reviewed journals in 2019. Fellow Members of the CleanImplant Community 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
Until recently we showed here data and numerous images from a previous study with SEM/EDS results of older implants (Production Date 2012-2015). Unfortunately some manufacturers misused this information for commercial purposes and connected these older data to their implants of recent production -  in some cases ignoring contaminations on implants of new production. Thus, we decided to take the complete data off the net.   
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 ordered for a fee (PDF or printed version).