Clean Implant
/


the global quality campaign

 

Objective Analysis of Dental Implants - The Five-Step Approach 



 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.






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 (*).

We achieved another milestone for the CleanImplant Project! With more than 15.000 subscribers only on Facebook we reach a fair number of dental professionals. With your help the CleanImplant Community is one of the fastest growing communities in the dental world. This website registered already 20.000 sessions from dental professionals of more than 130 countries around the globe. Time to say THANK YOU! Your feedback is a great motivation for us. 

If you want to participate in our project you can now join us as a Fellow Member of the CleanImplant Community.  You will not only get independent and non-biased answers to your questions, but also a personalized certificate about the cleanliness of your chosen implant system. This and additional benefits will show your patients and referral practices that you care. Find all information here and sign in for your membership.

Thank you all for your overwhelming response and support that allows us to be a voice for better quality in implant dentistry.  


on behalf of the CleanImplant Team 

Dr. Dirk U. Duddeck, Managing Director CleanImplant Foundation and Guest Researcher at the Charité University Medicine Berlin



Anthogyr | Axiom

Anthogyr | Axiom

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis October 2015

LOT/Batch Number: 15-064185

Production Date: 2015-09

Comment:

Bredent | SKYclassic *

Bredent | SKYclassic *

CleanImplant Quality Mark 2017: Commissioned / pending

Current Images/Data based on: Single implant analysis Feb. 2015

LOT/Batch Number: 410233

Production Date: 2014-09

Comment:

BTI | Interna IIPA *

BTI | Interna IIPA *

CleanImplant Quality Mark 2017: 5 new implant samples from this manufacturer complied with criteria 2017-2018

Current Images/Data based on: Single implant analysis Jan. 2015

LOT/Batch Number: AD00541.Z

Production Date: 2014-02

Comment:

Camlog | Screwline

Camlog | Screwline

CleanImplant Quality Mark 2017 (not yet requested)

Current Images/Data based on: Single implant analysis June 2015

LOT/Batch Number: 0030057240

Production Date: 2015-01

Comment:

Dentsply Implants | Astra Osseospeed

Dentsply Implants | Astra Osseospeed

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis February 2015

LOT/Batch Number: 164800

Production Date: 2014-10

Comment: Blasted with titanium oxide

Implant Direct | InterActive (SBActive)

Implant Direct | InterActive (SBActive)

CleanImplant Quality Seal 2017: (not yet requested)

Current Images/Data based on: Single implant analysis Jan. 2015

LOT/Batch Number: 665013

Production Date: 2014-03

Comment:

Keystone | Genesis

Keystone | Genesis

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis March 2015

LOT/Batch Number: 4099

Production Date: 2011-03

Comment:

Medentika | M-Implant (Microcone)

Medentika | M-Implant (Microcone)

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis October 2015

LOT/Batch Number: 611231

Production Date: 2104-01

Comment: According to manufacturer technically identical with follow-up model "Microcone"

MegaGen | AnyRidge *

MegaGen | AnyRidge *

CleanImplant Quality Mark 2017: 5 new implant samples from this manufacturer complied with criteria 2017-2018

Current Images/Data based on: Single implant analysis September 2015

LOT/Batch Number: 141127A5001-01

Production Date: 2014-11

Comment:

MIS | V3 *

MIS | V3 *

CleanImplant Quality Mark 2017: Commissioned / pending

Current Images/Data based on: Single implant analysis Feb. 2016

LOT/Batch Number: W16001118

Production Date: 2016-02

Comment: Tiatnium Grade 5

Natural Dental Implants | REPLICATE *

Natural Dental Implants | REPLICATE *

CleanImplant Quality Mark 2017 Commissioned / pending

Current Images/Data based on: Single implant analysis Jan. 2015

LOT/Batch Number: 144004001R

Production Date: 2014-12

Comment: Root analogue Titanium-Zirconium hybrid implant

Neodent | Titamax

Neodent | Titamax

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis September 2015

LOT/Batch Number 800167964

Production Date: 2015-01

Comment:

Nobel Biocare | NobelActive

Nobel Biocare | NobelActive

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis Nov. 2015

LOT/Batch Number: 12051430

Production Date: 2015-09

Comment:

NucleoOss | T4 (Tpure) *

NucleoOss | T4 (Tpure) *

CleanImplant Quality Mark 2017: 5 new implant samples from this manufacturer complied with criteria 2017-2018

Current Images/Data based on: Single implant analysis Feb. 2015

LOT/Batch Number: 133771

Production Date: 2014-03

Comment: Model T4 is technically identical with the new Tpure due to name change.

Osstem | TSIII SA

Osstem | TSIII SA

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis June 2015

LOT/Batch Number: FTN14G019

Production Date: 2014-07

Comment:

SGS | P7

SGS | P7

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis January 2015

LOT/Batch Number: 12P0764D75C61A61S77

Production Date: 2014-07

Comment:

Southern | IB i *

Southern | IB i *

CleanImplant Quality Mark 2017: Commissioned / pending

Current Images/Data based on: Single implant analysis March 2015

LOT/Batch Number: 262G04

Production Date: 2015-01

Comment:

Straumann | Pure Ceramic

Straumann | Pure Ceramic

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis

LOT/Batch Number: HF314

Production Date: 2014-06

Comment:

Sweden Martina | Premium

Sweden Martina | Premium

CleanImplant Quality Mark 2017: (not yet requested)

Current Images/Data based on: Single implant analysis January 2015

LOT/Batch Number: 0000187050

Production Date: 2014-10

Comment:



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!