Clean Implant
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the global quality campaign

 

Objective Analysis of Dental Implants - The Five-Step Approach 

From implant sample acquisition to environmental requirements necessary for unpacking and the subsequent analysis process, the CleanImplant Foundation guarantees unbiased research at the highest scientific level

STEP 1: SAMPLE ACQUISITION 

For the new Trusted Quality Mark five samples of each implant (surface-)type will be selected from every company, using a mixture of mystery shopping (two samples) and direct factory order (three samples) to ensure that samples are selected randomly. 

STEP 2: ISO CLASS 5 CLEANROOM ENVIRONMENT - DIN EN ISO 14644-1

In order to avoid artifacts on the unpacked implant samples during their transfer into the SEM, all implants have to be unpacked and analyzed in the scanning electron microscope under cleanroom conditions according to Class 100 US Fed. 209 and ISO class 5 (DIN EN ISO 14644-1). 

STEP 3: SEM ANALYSIS PROCESS ACCREDITATION - DIN EN ISO/IEC 17025 

All collected samples are subjected to the same quality analysis protocol. All independent laboratories have to prove a Quality Management System according to DIN EN ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories). These laboratories have to implement a quality system aimed at improving their ability to consistently produce valid results. This includes the quality standard according to DIN EN ISO 9001:2015. The laboratories undergo regular audits and multi-annual reassessments by external, independent accreditation bodies (e.g. DAkkS).


STEP 4: FSHR - FULL-SIZE HIGH-RESOLUTION SEM IMAGING

In order to achieve a complete overview of the sample as well as comprehensive surface quality information in high resolution, implants are scanned at a magnification of 500x in “Automated Image-Mapping” mode. 

This technique produces more than 360 single high-resolution SEM images that are digitally composed to one large image with an extremely high resolution. Thus, the complete implant surface will always be assessed at a 120° angle - in other words: 

No chance to "cherry-pick" nice-looking implant areas and ignore areas with impurities. The composed FSHR-image makes it possible to count the particles in the visible field and to identify areas of interest for the subsequent spot-analyses. For a full protocol and extensive quality assessment of one single implant, up to 500 SEM images and numerous additional elemental analyses will be generated.


STEP 5: PEER-REVIEW PROCESS

The analytical reports are screened by the Scientific Advisory Board in a peer-review process. Based on this data the analyzed implant type can be issued with the CleanImplant Trusted Quality Mark. The final report will be available on this website.


Thus, results shown in the gallery below cannot be compared to the new results of 2017/2018 analyses under stringent requirements. 

Implants from the recent production period that are in the process of - or have already received - the "CleanImplant Quality Mark 2017/2018" award, are indicated with an asterisk (*).



Anthogyr | Axiom
Bredent | SKYclassic *
BTI | Interna IIPA *
Camlog | Screwline
Dentsply Implants | Astra Osseospeed
Implant Direct | InterActive (SBActive)
Keystone | Genesis
Medentika | M-Implant (Microcone)
MegaGen | AnyRidge *
MIS | V3 *
Natural Dental Implants | REPLICATE *
Neodent | Titamax
Nobel Biocare | NobelActive
NucleoOss | T4 (Tpure) *
Osstem | TSIII SA
SGS | P7
Southern | IB i *
Straumann | Pure Ceramic
Sweden Martina | Premium



Get to know and not just believe

If you want to show your patients and referal colleagues that they can trust in your decision for an implant system based on in-depth quality assessments and unbiased information provided by independend and officially accreditet testing laboratories (DIN EN ISO/IEC 17025), the CleanImplant Foundation has the right equipment for you and your practice. 

STEP 1: Join the CleanImplant Community. 

Be part of the global project, support our mission and protect your patients.  

STEP 2: You can apply for a personalized certificate for your practice. We check our database for your favorite dental implant system. If the result of analysis meets the criteria of a clean implant - according to the CleanImplant consensus paper. Show your patients or referral practices this certificate about your implant of choice. Let your patients know even in the waiting room that they can trust in your decision for high-quality medical device. Demonstrate the cleanliness of your implant system in use. The personalized certificate will be available exclusively for registered CleanImplant members. Join the CleanImplant Community and support our project!