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Head: Prof. Dr. Dr. Joachim E. Zöller Interdisciplinary Policlinic for Oral Surgery and Implantology Dep. for Craniomaxillofacial and Plastic Surgery; E 01 Trakt D University of Cologne Kerpener Str.

1 Head: Prof. Dr. Dr. Joachim E. Zöller Interdisciplinary Policlinic for Oral Surgery and Implantology Dep. for Craniomaxillofacial and Plastic Surgery; E 01 Trakt D University of Cologne Kerpener Str Cologne, Germany (BDIZ EDI) Implant-Study 2014/2015 Quantitative and qualitative element-analysis of implant-surfaces by SEM and EDX FINAL STUDY REPORT EXTRACT (LEADER) In cooperation with the European Association of Dental Implantologists BDIZ-EDI Quality & Research Committee Project manager / Author: Dr. med. dent. Dirk U. Duddeck Head of Surface Analyses Mobile: Fax: Mail: duddeck@mmri.berlin Technical analyses carried out by: medical materials research institute berlin mmri.berlin! Dr. Dirk Duddeck! Klingsorstrasse 116! Berlin! Germany Note: All materials in this report, including images are copyright protected and are the exclusive property of the author

2 List of Implants Manufacturer / Distributor Analyzed Product(s) LOT number Page 3M ESPE Dental Products MDI Collared Intermediate O-Ball N A. B. Dental Devices Ltd. Titan Implant Titan Implant - Laser Sintering ACE Surgical Supply Co. Inc. Infinity Internal Hex Adin Dental Implants Sys. Ltd. Touareg S AGS Medikal implance BL 1,50302E Alpha-Bio Tec Ltd SPI Spiral Implant Alpha Dent Implants LTD Implant Active alphatech Implantate BONITex DUOTex Anthogyr Axiom PX Argon Medical Konus K3Pro Rapid Konus K3Pro Sure K3 pro Zirkon Avinent Implant System s.l. Coral Ocean Axis biodental SA Implant M K.S.I. Bauer-Schraube K.S.I. Schraubenimplantat BEGO IMPLANT SYSTEMS Semados RI Semados S Semados RSX Semados Mini Bicon Dental Implants Bicon-Integra-Ti A 153 Bio3 Implants GmbH Implant Advanced Bio Concept Co., LTD. Bone Level Implant ZAG Biodenta Swiss AG Dental Implant TP BIOHORIZONS TLX TLXP BIOMET 3i LLC 3iT OSSEOTITE NanoTite Biotec S.r.l. BT SAFE BONE DL P REV1 199 Blue Sky Bio LLC. Implant Internal Taper; Regular bredent medical bluesky SKYclassic White-Sky BTI Biotechnology Institute Interna IIPU AD02159.Z 229 Interna IIPA AD00541.Z 235 unicca IIPUCA AE03513Z

3 List of Implants Manufacturer / Distributor Analyzed Product(s) LOT number Page C-Tech Implant Esthetic Line CAMLOG Biotechnologies AG Screw Line Conelog Screw Line isy Champions-Implants GmbH WIN! PEEK (R)evolution Clinical House Europe GmbH PerioType Rapid C COHO Technology Co., Ltd. Zibone P Cortex dental implants Classix WO Dynamix WO Cumdente GmbH AS-Implant Dentalpoint ZERAMEX P8 K DENTALRATIO OKTAGON A Dentatus AB ANEW implant System DENTAURUM GmbH&Co. KG tiologic Dentegris Deutschland GmbH Sinus-Lift Implant Dentium Co., Ltd. Superline FX4012SW G15D DENTSPLY Implants DI Ankylos CX B DI AstraTech-Osseospeed DI Xive S plus B DIO implant UF(II) P Dyna Dental Engeneering BV Dyna Helix FairImplant GmbH FairTwo GC Tech.Europe GmbH Aadva Standard Implant Narrow Glidewell Direct Inclusive HI-TEC Implants Ltd. NTI-13mmSR LOT IDI-Implants Diffusion International IDB Dr. Ihde Dental AG Allfit KOS MGL Allfit TPG NI32077A ImplantDirect InterActive-SBActive InterActive-SBM implantswiss/novodent Bone Level Impro Dental Implant Germany Implantem JDental Care s.r.l. JD EVOLUTION EV jmp-dental GmbH m1-mini-implant A Keystone Dental, Inc. Genesis Straight Implant Klockner S.A. VEGA LASAK Ltd. BioniQ Implant

4 List of Implants Manufacturer / Distributor Analyzed Product(s) LOT number Page Leader Italia S.r.l. Implus Implant I Tixos Implant Internal Hex H m&k dental Jena Trias Mini-ball Medentika Implant GmbH M-Implant medentis medical GmbH ICX - templant ICX White / Medical Instinct Deutschland GmbH BoneTrust plus Megagen Italia S.R.L. AnyRidge A MIS-Implants Technologies Ltd. MIS-C1 W MIS-Seven W V W nature-implants GmbH NBM-Nano Bridging Molecules SA SurfLink Natural Dental Implants AG Replicate Zahn R 553 Replicate Zahn R 559 NeoBiotech Co.,LTD. IS-II active Fixture-Wide F Neodent TitamaxCM Neoss GmbH ProActive Tapered Nobel Biocare AB NobelActive Internal RP NucleOSS T4 Implant OCO Biomedical Engage OSSTEM IMPLANT TSIII SA FTN14G OT Medical GmbH BiCortic 16356/ F / F / F / Paltop Advanced Dental Solutions Advanced Dental Implant WO Phibo Dental Solutions SL Aurea TSA-Advance Phoenix-Implants GmbH CO-XG PROWITAL GmbH prowital plus R Schütz Dental GmbH Cylindrical cone SDS Swiss Dental Solutions AG / Metoxit AG SGS International LTD. Mini conetop Micro retention SDS Ziraldent RD C-P1 C-P7 13M0032D78 C65A P0764D75 C61A61S SHINHUNG MST CO., Ltd. Luna RBM ME0303D

5 List of Implants Manufacturer / Distributor Analyzed Product(s) LOT number Page SIC invent AG SICmax SICvantage max SOUTHERN IMPLANTS IB i G DCT 225G Straumann GmbH Pure Ceramic HF Bone Level Roxolid HV Sweden & Martina SPA Global Premium TA Dent GmbH Zahnimplantat T Thommen Medical AG SPI Element TRATE AG ROOTT Dental Implant compressive E0916KL02C TRI Dental Implants Int. AG TRI-Vent TRINON Titanium GmbH QK-Implant F31257K VI-STOM Vite Bicorticale vitaclinical CI Zirconia Implant Zimmer Dental Inc. TMTB TSVMB ZL Microdent GmbH Natural Lock A Z-Systems AG Z5c ZV3-Zircon Vision Standard Zirkon Implantat a

6 1 Background and Aim Implant surfaces are modified by microstructures and surface extension to improve osseointegration. Numerous studies showed an increased adhesion and osteoblastic matrix-production on retentive titanium surfaces. In 2008 the University of Cologne, Germany and the BDIZ EDI (European Association of Dental Implantology) with its Quality and Research (Q&R) Committee ( performed a scanning electron microscopic study and analyzed the surfaces of 23 enossal titanium implants of several manufacturers at the Interdisciplinary Policlinic for Oral Surgery and Implantology, Department for Craniomaxillofacial and Plastic Surgery, University Cologne 1. The tested implants showed isolated and/or extensive deposits. Depending on manufacturing process, accumulations of organic material (carbon) or inorganic material like aluminum, silicon, phosphor, sulfur, chlorine, potassium and calcium were found. In we performed the same protocol on 57 dental implants from different manufacturers. Although some manufacturers have made substantial improvements since our first survey in 2008, the study in again singled out a few implants with larger areas of surface blasting residue and selective organic impurities. 2 In we doubled the numbers of samples again and collected 135 dental implants from 95 companies. While using the same material and methods regarding the technical setup this study allows comparisons to the results of previous studies. As a continuance of the two studies cited above the aim of this study is to investigate improvements of manufacturing and quality management as well as to determine any increases in the quality level of the participating manufacturers and implant companies. SEM images and elemental analyses of all 135 implants will be the fundament for a public data base that is going to be published in Using these data an independent foundation as a non-profit organization will establish a global quality campaign to provide implantologists with reliable information about the quality of dental implants. 1) Duddeck DU; Comparative investigation of various implant surfaces by SEM-Analysis. (Posterpresentation) 18th Annual Scientific Meeting of the European Association of osseointegration, 30 September - 3 October 2009, Monaco, France 2) Duddeck, DU. et. al; Surface characteristics and quality of implants in sterile packaging, EDI Journal

2 Material and Method / Study Protocol 2.

equipped with a high-sensitivity backscattered electron detector that allows compositional and topographical imaging

Workstation with Phenom prox Scanning Electron Microscope Without touching the surface, each implant will be taken out

7 2 Material and Method / Study Protocol 2.1 Scientific Workstation and Test Procedure The scientific workstation is a Phenom prox Scanning Electron Microscope, equipped with a high-sensitivity backscattered electron detector that allows compositional and topographical imaging modes. EDX analyses are performed with a thermoelectrically cooled Silicon Drift Detector (SDD). Workstation with Phenom prox Scanning Electron Microscope Without touching the surface, each implant will be taken out of the package with sterile forceps and will be fixed on the sample holders. After the vacuum is generated in the electron microscope imaging and EDX-analyses will be completed. Fixed implant (example) on the sample holder - 6 -

8 2.2 3D Roughness Reconstruction With a specific 3D roughness reconstruction application, based on a shape from shading technology, the SEM system used in this study is able to generate threedimensional images and submicrometer roughness measurements. 3D imaging helps to interpret sample characteristics and makes images understandable. In addition the system is able to measure the average roughness (Ra) and the roughness height (Rz). Due to shape-from-shading technology Ra and Rz data in this study are to be generally understood merely as approximate values. 2.3 SEM-Examination of Implant Surface Scanning electron microscopy (SEM) enables the topical evaluation of the implant surface. In particular at low voltages and small working distances, images with high contrast can be obtained. The high-sensitivity backscattered electron (BSE) detector is generating images in compositional and topographical modes to a magnification of x. Besides information about morphology and surface topography, the BSE detector allows to draw conclusions about the chemical nature and allocation of different remnants or contaminations on the sample material. 2.4 Qualitative and Quantitative Analysis of Implant Surfaces (EDX) Energy Dispersive X-ray Spectroscopy (EDX) analyzes X-rays generated by the electrons of the electron beam (CeB 6 electron source) while they are interacting with the sample. Each element emits specific X-ray peaks. The element identification software allows to identify even hidden elements within the sample via the spot mode analysis. All results are verified using iterative peak stripping deconvolution. An area-analysis and one or more spot analyses are performed for each tested implant (analysis of spots and areas by EDX). An area-analysis covers the entire implant area in the focus of the microscope. For a spot analysis, the electron beam is focused on a specific area to get information about selective accumulations on the implant surface. This final report shows area scans from every implant in the cohort. The following images and EDX data/graphs illustrate examples of spot analyses. Note: Labels of these spot analyses have been removed or made illegible due to threads of legal action by single manufacturers. Detailed reports in high resolution about single implant analyses (20-50 pages for each implant) are available on request. The image quality of this final report was reduced in order to reduce the size of the electronic file

3 Results and Examples of Spot Analyses The large amount of analysed samples

The majority of all implants in this study presented a high standard of quality

However, a fair number of implants surprised with major pollution on the implants

9 3 Results and Examples of Spot Analyses The large amount of analysed samples demonstrated a wide spread of production quality. The majority of all implants in this study presented a high standard of quality showing a precise outer geometry and no inorganic or organic particles. However, a fair number of implants surprised with major pollution on the implants surface which may have been caused by the various production-, handling- or packaging processes. 3.1 Surface anomalies Single implants showed cutting burrs ( µm) that remained on the surface even after the blasting and/or etching process. Other implants showed areas with anomalies in the oxyde layer

Significant amount of iron, chromium and nickel in the elemental spot analysis of particles (20-50

10 3.2 Metal particles The spot analyses revealed a large variety of metalic remnants both as isolated particles or embedded in an organic matrix fixed on the implant surface. Significant amount of iron, chromium and nickel in the elemental spot analysis of particles (20-50 µm) on some implant samples may be a hint for recycled or polluted blasting material containing particles of stainless steel

11 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 are each embedded in larger organic contaminants ( µm)

One implant showed significant element traces of

Some implants showed remnants of aluminum oxide

12 One implant showed significant element traces of zinc < Zn >, carbon < C > and Calcium < Ca > in numerous particles (5-20 µm) that covered the surface (upper image). Some implants showed remnants of aluminum oxide as consequence of the previous blasting process as seen in the image below

13 Surprisingly even antimony < Sb > (as seen in the two images below) and tungsten < W > (next page) were found in the EDX analysis

However, a significant number of implants showed a systematic

14 3.3 Organic contaminants Single organic particles (less than 5 particles) were found on many implants. 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

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17 Two samples showed significant traces of carbon and fluorine when fibres (5-50µm) were analysed that looked like remnants of PTFE (Teflon)

18 4 Synopsis Title of Study: Implant-Study 2014/2015 Quantitative and qualitative element-analysis of implant-surfaces by SEM and EDX Investigator/s: Study centre: Study carried out by: Dr. Dirk U. Duddeck Interdisciplinary Outpatient Dep. For Oral Surgery and Implantology, Dep. for Craniomaxillofacial and Plastic Surgery, University of Cologne mmri.berlin - medical materials research institute berlin Klingsorstrasse 116, Berlin, Germany Studied period: November 2014 December 2015 Methodology: Phenom prox Scanning Electron Microscope, equipped with high-sensitivity backscattered electron detector (compositional & topographical modes) EDX Analysis: Detector type: Silicon Drift Detector (SDD) Thermoelectrically cooled (LN 2 free) Detector active Area: 25 mm 2 X-ray window: Ultra-thin Silicon Nitride (Si 3 N 4 ) window allowing detection of elements C to Am Energy resolution Mn Kα 140 ev Max. Input count rate: 300,000 cps

19 5 COORDINATING INVESTIGATOR(S) SIGNATURE(S) STUDY TITLE: STUDY AUTHOR (S): Implant-Study 2014/2015 Quantitative and qualitative element-analysis of implant-surfaces by SEM/EDX Dr. Dirk U. Duddeck Interdisciplinary Policlinic - Dep. for Oral Surgery and Implantology, Dep. for Craniomaxillofacial and Plastic Surgery, University of Cologne, Head: Prof. Dr. Dr. Joachim E. Zöller, Address*: Kerpener Str. 62, D Köln, Germany duddeck@mmri.berlin *) Note: Since January 1 st 2016 the author is guest researcher at the Charité University Medicine Berlin, Campus Benjamin Franklin, Department of Prosthodontics, Geriatric Dentistry and Craniomandibular Disorders; Head: Prof. Dr. Florian Beuer You may reach the author under the following address: mmri.berlin, Klingsorstrasse 116, Berlin, Germany I have read this report and confirm that to the best of my knowledge it accurately describes the conduct and results of the study. PRINCIPAL INVESTIGATOR: Dr. Dirk U. Duddeck DATE: December 31,

20 6 SEM Images and EDX data Note: The images and EDX data shown in the following pages represent only part of the research data. The surface qualities visible in the images should not be mistaken as the concluding result of each implant

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22 Leader Implus Implant LOT I D Roughness Reconstruction

23 Surface-Topography - Material Contrast Images (Thread) Phenom camera Field of view 500x 1.000x 1.500x 2.000x

24 Surface-Topography - Material Contrast Images (Thread) 2.500x 5.000x 7.500x x

25 Surface-Topography - Material Contrast Images (Body) Phenom camera Field of view 500x 1.000x 1.500x 2.000x

26 Surface-Topography - Material Contrast Images (Body) 2.500x 5.000x 7.500x x

27 EDX Analysis Area Field of view Area Quantitative elemental analysis Qualitative elemental analysis

28 Leader Tixos Implant Internal Hex LOT H D Roughness Reconstruction

29 Surface-Topography - Material Contrast Images (Thread) Phenom camera Field of view 500x 1.000x 1.500x 2.000x

30 Surface-Topography - Material Contrast Images (Thread) 2.500x 5.000x 7.500x x

31 Surface-Topography - Material Contrast Images (Body) Phenom camera Field of view 500x 1.000x 1.500x 2.000x

32 Surface-Topography - Material Contrast Images (Body) 2.500x 5.000x 7.500x x

33 EDX Analysis Area Field of view Area Quantitative elemental analysis Qualitative elemental analysis

PRELIMINARY STUDY RESULT

(BDIZ EDI) Implant-Study 2014/2015 Quantitative and qualitative element-analysis of implant-surfaces by SEM and EDX PRELIMINARY STUDY RESULT Name of Manufacturer: Medical Instinct Deutschland GmbH Analyzed