BIORESORB BIORESORB DIRECTOSS TM VILET BIOMATERIALS KONTOUR. VILET II QUICK BIORESORB Macro Pore COLLAGEN MEMBRANE VILET VILET REGUARDE TM

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1 BIOMATERIALS DIRECTOSS TM VILET II QUICK BIORESORB Macro Pore COLLAGEN MEMBRANE RESORBABLE MEMBRANESREGUARDE TM VILET VILET BIORESORB BIORESORB REGUARDE TM KONTOUR TM ADAPT VILET TM KONTOUR BIORESORB REGUARDE REGUARDE TM Resorbable Collagen Membranes BIORESORB Macro Pore Bone Regeneration Material KONTOUR TM ADAPT Resorbable Collagen Membranes DirectOss Natural bovine bone substitute VILET Resorbable Sutures VILET II Quick Resorbable Sutures DirectFlon With black needle

2 Biomaterials BIORESORB Macro Pore DirectOss REGUARDE TM Resorbable Membranes Kontour TM Adapt DirectFlon VILET TM and VILET II Quick TM Resorbable Sutures

3 BIORESORB Macro Pore Helps create bone ß-Tricalcium Phosphate Bone Regeneration Material with Advanced Porosity BIORESORB Macro Pore is an osteoconductive, pure-phase ß-Tricalcium phosphate bone grafting material developed via a patented process that creates a porous structure most similar to human bone. The interconnecting micro & macro porous structure gives the advantage of allowing vascularization and cell transport into and throughout the particle, leading to new bone deposits within the particles themselves. This results in highly-predictable bone formation. Lateral wall sinus elevation. 100% BIORESORB mixed with blood Biopsy taken at 7 months. Histology at 7 months improved bone regeneration with a high activity of osteoblasts, homogenous cortical structures and no signs of inflammation. Our results with BIORESORB without a combination of autologous bone are predictable and uncomplicated for the patient. Our histologic research has confirmed the excellent osteoconductive properties of this material. Achim Schmidt, DDS Munich, Germany 3

4 BIORESORB Macro Pore Why BIORESORB? Interconnecting Porosity = Predictability The open and interconnecting porosity of BIORESORB granules enable bone growth throughout the complete particle, unlike the icing effect of bone that occurs in less porous materials. The micropore sizes range from μm, while the macropore sizes are μm. This unique combination closely mimics the porous structure of human bone and leads to predictable bone formation. Advanced Osteoconductivity The advanced chemical structure of BIORESORB ß-TCP granules facilitates the rapid formation of osteoblasts the precursor to osteogenesis. BIORESORB Macro Pore not only offers advanced osteoconductivity, it is also osteotropic due to the high calcium ion composition. Resorption As with all materials, the rate of bone remodeling is patient and site dependant. However, the resorption rate of BIORESORB Macro Pore has proven similar to the rate of new bone growth. The ß-TCP resorbs simultaneously with the formation of new, natural bone within the augmentation site. Biocompatible ß-Tricalcium phosphate has been shown to be 100% biocompatible in numerous studies. There have been no unfavorable tissue reactions or immunologic reactive rejections. In a properly prepared recipient site, BIORESORB Macro Pore displays very high integration to the host bone without any soft tissue encapsulation or pathological reactions. Hydrophilic The highly-porous BioResorb granules are extremely hydrophilic, resulting in a very cohesive and easy to handle material after hydration. This allows for the graft to be placed in defects of any size and shape with relative ease. SEM magnification x 100 of BIORESORB Macro Pore Odontogenic keratocyst SEM magnification x 10,000 of BIORESORB Macro Pore 6 months after cyst removal and placement of BIORESORB Macro Pore. Complete restitution of bone structure.* *SOURCE: Goran Kneževic ; Radiological Evaluation of the Healing of Bone Defects Filled with BIORESORB ; Acta Stomotol Croat. 2007;41(1):66-73 I have found BIORESORB to provide the most predictable results. Because of the advanced porosity, I can mix the particles with the patients own blood and create an osteoinductive graft without using autogenous bone. 4 Dennis Smiler, OMS Encino, CA

5 BIORESORB Macro Pore Granule size BIORESORB Macro Pore is available in various granule sizes to meet every indication Granule size Vial Contents Ref. No µm 1 x 0,5 ml µm 1 x 0,5 ml x 1,0 ml x 2,0 ml µm 1 x 0,5 ml x 1,0 ml x 2,0 ml Set µm 5 x 0,5 ml µm 5 x 0,5 ml x 1,0 ml x 2,0 ml µm 5 x 0,5 ml x 1,0 ml x 2,0 ml Sinus lift µm 1 x 1,0 ml x 2,0 ml

6 DirectOss Natural bovine bone substitute for dental surgery ANORGANIC CANCELLOUS BONE GRAFT GRANULES 100% Natural Safe, Biocompatible Highly Purified Large Inner Surface Area Multi-Porosity Natural DirectOss TM is a natural hydroxyapatite extracted from bovine cancellous bone. Safe This bovine bone has been harvested from herds in Australia (which has historically been BSE free) and processed in accordance to EN ISO Each animal undergoes a pre and post-mortem health inspection and then only extremity bones are used from each animal. Purified DirectOss TM undergoes a proprietary multi-step purification process that removes organic content from the bone. This process results in DirectOss TM being chemically and structurally comparable to mineralized human bone (nanocrytalline natural apatite). In addition, DirectOss TM has been shown to be biocompatible and has been terminally sterilized to an SAL of Protein Analysis Comparison Crude Protein (%) DirectOss Bio-Oss * Pure Protein (0.062%) 0.04% 0,118% ( 0.12%) Collagen (0.05%) Others (Nitro Comp.) (0.006%) Ref. NuOss *, a Bone Grafting Material for Oral Surgery: A Comparative Study with Bio-Oss * by Collagen Matrix Inc. Ref. Biomaterials 2001; 22: DirectOss TM Ca (wt.%) P (wt.%) Ca (at.%) P (at.%) Ca/P ration Large inner surface area An additional benefit provided by this interconnected porous structure is that if provides DirectOss TM with a larger surface area than some comparable products currently in the market. This provides for additional area to support new bone deposits while also making DirectOss TM a highly hydrophilic grafting material. 6 * Registered Trademarks of Geistlich and Ace Surgical Supply Co., Inc.

7 DirectOss Multi-Porosity This proprietary process results in DirectOss TM having a structure comprised of a combination macropores, mesopores and micropores. The advantage of this 3 dimensional interconnected highly porous structure is that it allows for vascularity and cell transport into and through out this structure. This then allows for proliferation of new bone growth throughout each granule of DirectOss TM. Granules MacroPore (>100μM) MesoPore (10-100μM) MicroPore (<100μM) 100 BET (Surface Area) Comparison Inner Surface Area (m 2 /g) DirectOss Bio-Oss * Products NuOss * Ref. NuOss *, a Bone Grafting Material for Oral Surgery: A Comparative Study with Bio-Oss * by Collagen Matrix Inc. Ref. Biomaterials 2001; 22: Inner Surface Area (m 2 /g) DirectOss Bio-Oss * NuOss * Applications Reconstruction of oral and maxillofacial defect (alveolar ridge, periodontal defects, filling of extraction sockets, and maxillary sinus floor, etc.) Case courtesy of Dr. Pedro Peña (Madrid, Spain) Granule version Syringe version Granule size Weight Reference# Granule size Weight Reference# mm 0.25g /0.54CC DXCA mm 0.50g /1.08CC DXCA mm 1.0g /2.15CC DXCA mm 0.50g /2CC DXCA mm 2.0g/4.24CC DXCA mm 2.0g/4.24CC DXCA mm 0.25cc syringed DXCA251025S mm 0.5cc syringed DXCA251005S mm 1.0cc syringed DXCA251010S * Registered Trademarks of Geistlich and Ace Surgical Supply Co., Inc. 7

8 REGUARDE TM Resorbable Collagen Membranes For Dental Surgery Type I Bovine Collagen Matrix Indicated For Use in Guided Tissue Procedures to Enhance Wound Healing REGUARDE TM Collagen Membranes are resorbable, cell-occlusive barrier membranes used in guided tissue and bone regeneration procedures in oral surgery to manage oral wounds and assist in wound healing. They are commonly used in periodontal surgery as well as dental implant, bone defect, and ridge augmentation procedures. The membranes are manufactured from highly purified type I collagen and have characteristics specifically designed to meet the needs and preferences of the patient and clinician. Features Higher mechanical strength for membrane stabilization in situ using either sutures or resorbable tacks Longer in vivo stability and resorption time, weeks, for sustained function Optimized flexibility and rigidity for better space maintenance, which allows for desired tissue in-growth Either side of the membrane can be placed towards the soft tissue or bone Easily trimmed and placed, wet or dry Highly purified type I collagen fibres derived from bovine Achilles tendon Gamma irradiated to sterilise Nonpyrogenic Cell occlusive - retards epithelium down growth Macromolecular pore size allows nutrient transfer 8

9 REGUARDE TM BIOMATERIALS REGUARDE TM Available in 3 Convenient Sizes Membranes Per Box Ref. No. 15 mm x 20 mm mm x 30 mm mm x 40 mm Preis Characterization of Collagen membranes Dependable Resorption Rate Test Reguarde TM Biomend Suture Pull-Out Strength (g) 350 ± ± 10* Pore Structure Permable to CA µm* Area (mm 2 ) In vivo Resorption (weeks) * Implementation time (week) *Reported from 510K (K Society for Biomaterials 9

10 Kontour TM Adapt Resobable Collagen Membrane Natural Easy of Use Sustained Protection Natural Kontour Adapt is made from a single layer of purified porcine peritoneum collagen rich tissue Purified Proprietary process assures the membranes are highly biocompatible resulting in minimal inflammation and foreign body response Performance/ Characterization Parameter Porcine Collagen Membrane Bio-Gide Hydroxyproline Content (Weight %) 11.7 ± 1.1% 11.8 ± 0.8% Suture Pull-out Strength 953 ± 110 g 330 ± 120g Conformability Highly Highly Bio-Gide * Kontour Adapt Bio-Gide * Kontour Adapt Giant Cells Score Weeks 8 Weeks 12 Weeks 16 Weeks Weeks 8 Weeks 12 Weeks 16 Weeks Easy of Use Either side of membrane may be placed against wound; does not require a specific orientation for use May be placed either dry or hydrated Does not cling to instruments or gloves when hydrated Easily conforms to defects and contours Can be easily repositioned once placed Has excellent strength to support tacking or suturing 10

11 Kontour TM Adapt Resobable Collagen Membrane Sustained Protection Initial slower rate of resorption protects wound during early critical period of wound healing Protects wound from undesired in-growth of soft tissue Provides an effective barrier function for up to weeks % Implant Remaining Implant Remaining New Collagen % New Collagen Supports wound Healing New host collagen is regenerated as membrane resorbs Time (Weeks) Figure 1. Plot of % implant remaining and % new collagen for Kontour Adapt Reference# Description Size KRMA1520 Kontour Adapt Membrane 15x20mm 15x20mm KRMA2030 Kontour Adapt Membrane 20x30mm 20x30mm KRMA3040 Kontour Adapt Membrane 30x40mm 30x40mm % Implant Remaining Implant Remaining New Collagen % New Collagen Time (Weeks) Figure 2. Plot of % implant remaining and % new collagen for Bio-Gide * Figure 3. SEM micrograph of the PCM (side A) at 50x magnification Figure 4. SEM micrograph of the PCM (side B) at 50x magnification * Registered trademarks of Geistlich Figure 5. SEM micrograph of the PCM (cross-section) at 50x magnification 11

12 DirectFlon PTFE Polytetrafluoroethylene (PTFE) is a nonabsorbable material of high biocompatibility which for many years has been used for production of cardiovascular surgery and membranes for guided bone regeneration. PTFE is also used for production of surgical suture. Properfies of dptfe thread lts unique softness and smoothness enables it to go through soft tissues minimizing microdamage reaction around tissue duct, which prevents from bacterial colonization in deeper layers of the wound. The thread does not retain the coiled shape after unpacking, which makes it easier to work with. The surgical knot made with a PTFE suture is durable and does not loosen. The ends of the suture do not cause irritation of the cheek, lips and tongue, unlike suture materials based on various monofilament fibres, which additionally may contribute to the formation of viral changes on mucous membrane. ln cantrast to braided sutures, especially those made from absorbable materials, DirectFlon does not absorb blood, saliva, bacteria and food residues. That promotes wound healing per primam intencionem. Despite its soft and delicate nature, DirectFlon firmly supports tissues during the whole healing process, in contrast to absorbable materials which maintain tissues only in the early stages of healing due to the presence of enzymes in the mouth. 12

13 DirectFlon eptfe vs dptfe Surgical sutures made from eptfe are used mostly in vascular and cardiac surgery. Pores in eptfe sutures are interlaced by soft tissues and vessels, so the sutures are permanently incorporated in the body. As far as wound closure in the oral cavity is concerned, this property is unnecessary - surgical sutures in the mouth are removed 7-10 days after surgery. DirectFlon is different: it is the first smooth PTFE surgical suture (dptfe) without micropores, which very effectively reduces dental plaque adhesion and accumulation of bacteria and food residues. lt is easy to remove due to lower capillarity. Black & White Innovative combination of a white PTFE suture with a black needle ensures excellent visibility in the surgical field. The black needle is weil visible under soft tissue. Thanks to this solution we can accurately determine the direction of the needle when it passes through the skin or mucosa. This is especially important in precise oral or plastic surgery. Needle mounting The way in which the needle is mounted - a smooth transition between the needle and the thread - contributes to minimizing trauma of the sewed tissues. Needle properfies Choosing a partner to produce needles, we took into account years of experience, as weil as opinions of renowned surgeons. Top quality is our priority. Our surgical needles are made of high quality steel with unique chemical composition. The hardness of the steel minimizes the risk of mechanical damage to the cutting surface during surgery. Needles maintain sharp cutting surface during stitching, which ensures precision of surgery. They do not undergo distortion, even when used for deformed tissue, such as a post-operative scar. needle mounting needle properties Standard in minimally invasive surgery The aforementioned features of DirectFlon surgical suture make it the most technologically advanced suture material for oral and plastic surgery. Jaroslaw Pospiech DDS,PhD Poland Parameters, structure and excellent needle quality of DirectFlon PTFE suture makes it a perfect material for stiching wounds in the skin and mucous membrane areas. I use DirectFlon with great success in augmentation, implant and periodontic surgery. Decidedly less after-treatment inflammatory complications as weil as better and faster wound healing was observed. DirectFlon supports tissues very weil, does not loosen, increases patient comfort and reduces physical discomfort of removal the stitches to mimimum. 13

14 DirectFlon Cases Clinical images of wounds in the oral cavity sutured with DirectFlon : immediately after surgery and 7 days later. After the 7-day period the mucosa does not show signs of inflammation, wounds heal per primam intencionem. ln most cases, after a week of healing, DirectFlon stitches can be removed. lmmediately after surgery 7 days after surgery 14

15 DirectFlon needle BLACK needle length needle crosssections suture length USP 3/0 4/0 5/0 6/0 13 Y 55 cm - - ID5DS135512B ID6DS135512B DS ½ circle 16 Y 55 cm ID3DS165512B ID4DS165512B ID5DS165512B - 19 Y 55 cm ID3DS195512B ID4DS195512B ID5DS195512B - 22 Y 55 cm ID3DS225512B ID4DS225512B - - needle SILVER needle length needle crosssections suture length USP 3/0 4/0 5/0 6/0 13 Y 55 cm - - ID5DS135512S - DS ½ circle 16 Y 55 cm ID3DS165512S ID4DS165512S ID5DS165512S - 19 Y 55 cm ID3DS195512S ID4DS195512S ID5DS195512S - 22 Y 55 cm ID3DS225512S cm - - ID5DM135512S ID6DM135512S DM 3/8 circle cm ID3DM165512S ID4DM165512S ID5DM165512S cm ID3DM195512S ID4DM195512S ID5DM195512S cm ID3DM225512S ID4DM225512S - - DS: round needle with cutting blade - The needle is designed for surgical procedures where only minimal tissue traumatization is desired, but excellent penetration, better than with round needles, is still required. Provides a smooth transition between the hard tissues. DM: needle with reverse cutting blade, it has a specially designed tip - the third section of the length of the needle is sharp, while the remaining part has an oval cross-section, flattened for better grip in a vise. Thanks to its unique properties it can be successfully used in many surgical procedures. 15

16 VILET and VILET II Quick Vilet Vilet Vilet II Q Vilet II Quick Vilet is a braided coated synthetic absorbable suture made is from a absorbable braided coated synthetic absorbable Vilet II Quick is a Vilet is a braided coatedvilet synthetic suture Vilet suture II Quick is a braided coated fast-abso polyglactin (PGLA) made from polyglactin (PGLA) suture made from made of from (PGLA) suture made from 100% polygycolic acid (PG1 Maintain approximately 75-85% its polyglactin original strength at two weeks and 50-65% of its original strength at 3 weeks post implantation.* 75-85% Maintain approximately 75-85% strengthapproximately at 60-70% Maintain approxim Maintain approximately of its original strength at of its original Maintain of its origin Completely resorbs in days* weeks and 50-65% its original strengthpost at 3implantation.* weeks post implantation two weeks and 50-65% oftwo its original strength at 3ofweeks post implantation.* days* Completely resor Completely resorbs in 42 Product is equivalent to Vicryl** post implantation.* Completely Completely resorbs in days* resorbs in days* Vilet II Quick is a braided coated fast-absorbing synthetic absorbable Product is equivalent to Vicryl** Productacid is equivalent Product is Equivalent to VicrylProduct Rapide**is Equivale suture made from 100% polygycolic (PGA). to Vicryl** Maintain approximately 60-70% of its original strength after 1 week post implantation.* Completely resorbs in 42 days* Both Products FeatureBoth Products Fea High tensile strengw the critical Needles High tensile strength throughout Excellent knot secu Excellent knot security and tie down Superb 3/8 Circle handling and smooth Superb tissuehandling passagean Reverse Cutting Reliable/consistent Reliable/consistent absorption profile &Meet or exceeds th Meet or exceeds the USP EP requirements C-3 Race track style packaging Race track style pa that insures sutur 13 mm Proprietary 300 se Proprietary 300 series needles which combin with increased nee with increased needle sharpness Product is Equivalent to Vicryl Rapide** Both Products Feature High tensile strength throughout the critical wound healing period Excellent knot security and tie down Superb handling and smooth tissue passage Reliable/consistent absorption profile Meet or exceeds the USP & EP requirements Race track style packaging that insures sutures are delivered kink free Proprietary 300 series needles which combines superior ductile strength with increased needle sharpness FS-2 19 mm The 300 DifferenceThe 300 Difference Ductile Strength Sharper Needle Sharper Needle Suture Needles Suture Needles 100% increase in ductility. When needle bends it is less likely to break when reshaping Suture Needles 12% increase in penetration. Less force, less trauma. 120% 120% 100% 100% 80% 80% Suture Needles % Strength Ductile Strength Sharper Needle Resorption Profile Re % Strength The 300 Difference Ductile Strength 60% 60% 40% 40% 20% 20% 0% % 14 Resorption Profile Vilet Vilet Quick * Times are based on su 120% % Strength 100% Innovation. Quality. Innovation. 80% Quality. Service. 60% 40% 20% 0% Days * Times are based on subcutaneous tissue implantation studies in rats. ** Registered trademarks of Ethicon Inc.

17 BIOMATERIALS VILET and VILET II Quick Vilet TM Vilet Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box V385U Undyed C-3 V386U Undyed C-3 V392U Undyed FS-2 V Violet FS-2 V393U Undyed FS-2 V Violet FS-2 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm 3/8 Circle Reverse Cut 19mm Vilet II Quick Item # Size (USP) Length Color Needle Type Needle Shape QTY/Box VGQ Undyed C-3 VGQ Undyed FS-2 3/8 Circle Reverse Cut 13mm 3/8 Circle Reverse Cut 19mm Cross Reference Chart Implant Direct Reference # V385U V386U V392U V392U-S2 Suture Material Undyed PGLA Undyed PGLA Undyed PGLA Undyed PGLA Suture Size (USP) Suture Length Needle Type Ethicon* Reference # Look* Reference # C-3 J493G 493B PSN493V C-3 J494G 494B PSN494V FS-2 J422G 422B FS-2 J423G 423B VGQ386 Undyed PGA C-3 VR494 - VGQ392 Undyed PGA FS-2 VR496 - Hu-Freidy* Reference # PSN302V (violet) PSN303V (violet) PSN510FA (violet) PSN525FA (violet) Implant Direct Reference # Ethicon* Reference # Look* Reference # Hu-Freidy* Reference # FS-2 FS-2 C6 C6 C-3 P3 C3 C3 * Registered trademarks of Ethicon Inc., Look and Hu-Freidy 17

18 FAQ What are Vilet TM and Vilet II Quick TM sutures made from? Vilet is a coated synthetic absorbable suture made from polyglactin (PGLA) This Product is equivalent to Vicryl* Vilet II Quick TM is a coated fast-absorbing synthetic absorbable suture made from 100% polygycolic acid (PGA). This Product is equivalent to Vicryl Rapide* What are the benefits of advantages of using PGLA and PGA sutures? Both PGLA and PGA are known for maintaining a high tensile strength during the critical wound healing period (as compared to gut and chromic gut sutures). Furthermore, these materials are viewed as being both soft and being able to glide through tissues easily. Finally, PGLA and PGA sutures have been shown in studies to elicit less tissue reaction as compared to gut and chromic gut sutures. What kind of knot do you recommend for securing Vilet TM and Vilet II Quick TM sutures? It is recommended that the clinician use a multi-throw surgical knot technique for both Vilet TM and Vilet II Quick TM sutures. What are the values associated with each USP designation? USP Size Suture Diameter (mm) Knot Pull Tensile Strength (N) Note: Both Vilet TM and Vilet II Quick TM sutures have been rated per USP designation based on Tensile Strength only (and not suture diameter size). What are the needles sizes and curvatures based on? What is the absorbtion rates for Vilet TM and Vilet II Quick TM sutures? Vilet TM sutures absorbtion rates** Days Approximate % Tensile Strength Retained 14 81% 21 58% 28 25% % Totally Absorbed Vilet II Quick TM sutures absorbtion rates** Days Approximate % Tensile Strength Retained - Retained 5 67% 10 56% % 42 Totally Absorbed size = distance along the curvature of the needle. Needle Curvature 1/2 Circle 3/8 Circle 1/4 Circle 5/8 Circle Straight What types of Needles are available with Vilet TM and Vilet II Quick TM sutures? Both Vilet TM and Vilet II Quick TM are offered with a FS-2 needle (3/8 Circle w/ Reverse cut -19mm) and a C3 needle (3/8 Circle w/ Reverse cut -13mm). Reverse cut Can Vilet TM and Vilet II Quick TM sutures be resterilized? No, Vilet TM and Vilet II Quick TM sutures are intended for single use. What is the shelf life for Vilet TM and Vilet II Quick TM sutures? Both Vilet TM and Vilet II Quick TM sutures have a maximum shelf life of 3 years (from date product is packaged). 18 * Registered trademarks of Ethicon Inc. ** Times are based on subcustaneous tissue implantation studies in rats.

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