MICRODENT BONE REGENERATION PRODUCT CATALOGUE

MICRODENT BONE REGENERATION PRODUCT CATALOGUE

MICRODENT FACILITIES (MANUFACTURING AND COMMERCIAL SITES) CORPORATE MICRODENT

Quality as objective In order to completely and totally fulfil its customers requests, Microdent ensures that all products exceed the strictest regulatory requirements set by international health authorities. It is worth noticing that the raw material used in the manufacture of all Microdent products is of the hightest quality and strength, like the titanium used for the manufacture of dental implants. All production processes, assessed and validated by the international certification body DNV-GL, include cytotoxicity tests to ensure the correct cleaning of the Microdent products, as well as validation studies of the implant sterilization process, microbiological quality assessments, endurance, torque and fatigue tests... and a large number of studies with several national and international universities on clinical outcomes of Microdent s implants. Technology, innovation, professionalism... www.microdentsystem.com When choosing Microdent implants, customers are placing their trust in a large company with a professional career achieved with much effort, full of successes and supported by many of the most renowned implantologists in the country. Microdent facilities are equipped with cutting-edge technology where implants and implant components are manufactured under a targeted and rigorous unit quality control. Continuing education Microdent has shown a special interest in the area of education since its inception. Therefore, it often organizes and teaches continuing education clinical courses, seminars and hands-on workshops in order to provide practitioners with the appropriate knowledge and tools to achieve success in their work with patients. These courses take place in the company itself, where there is an auditorium and some practice rooms, but also in different cities in Spain. Human team Microdent has a team of highly-skilled, specialized technicians at the service of the professionals of implantology as well as a complete commercial network throughout the national territory which is complemented with an international distribution network in constant growth. Bone regeneration catalogue 3

PRODUCT PRESENTATION DIGITAL INFORMATION IMPLANT CATALOGUES MANUALS OTHER CATALOGUES QUICK-GUIDES 4

Backed up by 30 patents... Driven by the constant desire to improve and continuous research, Microdent products are protected by several patents and utility models that back up and protect our approach to oral implantology. nº1742465 MICRODENT trademark registration. nº9602250 Patent for bone expanders in Spain. nº6146138 Patent for bone expanders in USA. nº023801558 Patent for bone expanders in Europe. nº9800394 Patent for prosthetic Micro-pik fixation system. nº20002497 Patent for transmucosal dental implant. nº20002545 Patent for overdenture flat-ball. nº200102649 Patent for surgery security device. nº200102769 Patent for impact fixation dental implant. nº200102914 Patent for bicortical provisional implant. nº200200087 Patent for internal connection implant. nº200201614 Patent for improved dental implant. nºp200300602 Patent for overdenture adjustable retention system. nº200402082 Patent for biomechanical connection system. nº200800195 CORTICAL FIX patent - conformation of the maxillary sinus cavity. nºp200503064 NOVATECH patent - angular fixation system. nº200700408 Patent for dental implant. nº200701138 MRT patent - dental implant with integral locking system. nº200402082 RODAS system patent - bio-mechanical connection system between implant and prosthesis. nº200703251 Patent for implant retention key. nº200300041 Patent for fixation system of dental prosthesis. nº200500306 Patent for orthodontics implant. nº200801197 MV implant patent - insertion without drilling. nº200930627/a Patent for endosseus plataform for dental prosthesis implantation. nº201031083/ot Patent for bone expanders for guided dental surgery. nº201030002/5 Patent for disparallelism correction of dental implants. nº200203054 Patent for use of melatonin for bone regeneration for human and veterinary use as active product. nº200701563 CAPITEL abutment patent - prosthetic angular correction. nº200702213 OSSCILIA patent - spherical oscillating retainer for overdenture fixation. www.microdentsystem.com Bone regeneration catalogue 5

INDEX BONE REGENERATION CATALOGUE 08 BIOMATERIALS 11 TACK FIXING INSTRUMENTS 12 MEMBRANE FIXING KIT 13 OSTEOSYNTHESIS SCREWS 15 OSTEOSYNTHESIS SCREW FIXING KIT 16 TREPHINES 17 CLINICAL CASES 6

BONE REGENERATION www.microdentsystem.com Bone regeneration catalogue 7

BONE REGENERATION BIOMATERIALS Biomaterials used for reconstruction of bone defects must be biocompatible and possess remarkable manageability and shaping properties. Tecnoss laboratories have specialised in handling bone tissue and heterologous collagen. Gen-Os Tissue of origin Pre-hydrated collagenated cortico-cancellous porcine bone mix. Tissue collagen Preserved. Physical form Slightly radiopaque granules. Composition 100% granulated mix. Granulometry 250-1000 microns. Re-entry time 4 to 5 months depending on the characteristics of the grafting site. Packaging Vial of 0.25g, 0.50g and 1g. Clinical applications Oral Surgery: granulomas, odontogenic cysts and split-crest techniques. Periodontology: filling of deep infrabony defects and bifurcations. Implantology: universal filler used in the treatment of dehiscence and peri-implantitis, two-wall defects and sinus lift procedures with lateral and crestal access. If necessary, the graft may be stabilized by mixing it with Gel 0 and protected with the placement of a cortical Lamina membrane. Handling It must always be hydrated and thoroughly mixed with a few drops of sterile saline to activate its collagen matrix and to enhance its adhesivity. mp3 Tissue of origin Pre-hydrated collagenated cortico-cancellous porcine bone mix. Tissue collagen Preserved + 10% collagen gel. Physical form Pre-hydrated granules and collagen gel. Composition 90% granulated mix + 10% collagen gel. Granulometry 600-1000 microns. Re-entry time About 5 months. Packaging Syringes: 1 x 1.0cc and 3 x 0.5cc. Clinical applications Oral surgery and implantology: due to its particular formulation and granulometry, it is ideal for grafting in surgical procedures of maxillary sinus lift with lateral window. OsteoBiol Evolution or Special membranes are recommended to cover the antrostomy. Handling It is available in ready-to-use syringes and can be easily grafted, avoiding the hydration and manipulation phases. After adapting the material to the shape of the defect, it is necessary to remove nonstable residues prior to suturing the soft tissues. Apatos Tissue of origin Cortico-cancellous heterologous bone mix. Tissue collagen Degraded. Physical form Radiopaque granules of mineral hydroxyapatite. Composition 100% cortico-cancellous heterologous bone mix. Granulometry 600-1000 microns. Re-entry time About 5 months. Packaging Vial of 0.50g and 1g. Clinical applications Oral surgery: granulomas, odontogenic cysts and split-crest techniques. Implantology: universal filler used in the treatment of dehiscences and peri-implantitis, two-wall defects and lateral and crestal window sinus lifts. If necessary, the graft may be protected with the placement of a cortical Lamina membrane. Handling It must always be hydrated and thoroughly mixed with a few drops of sterile saline; it can also be mixed with patient s blood. 8

Technical procedures have been particularly developed for Osteobiol bone substitutes in order to preserve, though partially modified, the original collagen matrix of heterologous tissue, always aiming at preserving its positive biological functions while achieving an excellent biocompatibility at the same time. Putty Tissue of origin Collagenated cortico-cancellous porcine bone mix. Tissue collagen Preserved + 20% collagen gel. Physical form Bone putty with plastic consistency. Composition 80% granulated mix + 20% collagen gel. Granulometry 300 microns. Re-entry time About 4 months. Packaging Syringes: 1 x 0.5cc, 3 x 0.5cc, and 3 x 1cc. Clinical applications Implantology: versatile alveolar filler used to preserve crestal volume and to facilitate primary retention in case of immediate post-extraction implants. Ideal for the treatment of peri-implantitis and split-crest techniques. In cases of sinus lift with crestal access, it can be used together with Gen-Os to facilitate insertion. Oral surgery: versatile bone filler after dental extractions, granulomas and odontogenic cysts. Handling The product is injected and moulded to the morphology of the defect without compression, any non-stable residues must be removed prior to suturing the soft tissues. An Evolution membrane is recommended to protect the graft in peri-implant defects. Sp-Block Tissue of origin Heterologous cancellous bone. Tissue collagen Preserved. Physical form Heterologous rigid block. Composition 100% cancellous bone. Re-entry time Variable depending on characteristics and irroration grade of the grafting site and on the patient s clinical conditions - about 8 months. Packaging Block of 10x10x20mm and block of 10x20x20mm. Clinical applications Dental and Oral Surgery: vertical and horizontal large bone augmentation which require grafts with good scaffold properties. Maxillofacial Surgery: partial or total reconstruction of destroyed anatomical parts due to traumas and tumours. Handling It must be hydrated for 5-10 minutes with sterile, lukewarm saline solution or antibiotic. Afterwards, it can be moulded to the receiving site that must have been accurately decorticated to ensure maximum contact while keeping the bone block properly irrigated. The block must always be fixed with osteosynthesis microscrews and should be protected with a resorbable barrier (Evolution membrane). Duo-Teck Tissue of origin Equine lyophilized collagen felt and equine bone. Tissue colagen Preserved. Physical form Dried membrane covered with micronized bone. Composition Collagen felt and bone granules with collagen. Tickness About 1mm. Estimated resorption time About 15 days. Packaging 20x20mm. Clinical applications Oral Surgery and Implantology: indicated in all cases where a soft separation between tissues of different consistency is necessary. It can also be used to protect the sinus membrane in sinus lift procedures with lateral window, in order to prevent any accidental injuries caused by grafting biomaterial. Furthermore, it can be used for closing the antrostomy before repositioning the muco-gingival flap. Handling It must be rehydrated with lukewarm physiological solution. Once it acquires the desired plasticity, it can be easily placed in the grafting site with the micronized bone film side in contact with the graft and the smooth side in contact with the soft tissues. www.microdentsystem.com Bone regeneration catalogue 9

BONE REGENERATION BIOMATERIALS Evolution Tissue of origin Heterologous pericardium. Tissue collagen Preserved. Physical form Dried membrane with one smooth side and one micro-rough side. Composition 100% pericardium. Thickness Fine: 0.4mm+/- 0.1mm. Standard: 0.6mm+/-0.1mm. Estimated resorption time Fine: about 3 months. Standard: about 4 monts. Packaging(oval) Fine: 20x20mm; 30x30mm; 25x35mm. Standard: 20x20mm; 30x30mm; 25x35mm. Clinical applications Oral Surgery and Traumatology: in cases of large regenerations with risk of exposure (standard model). Implantology: ideal for covering the antrostomy and for protection of two-wall defects grafts (standard model). Periodontology: protection of grafted infrabony defects when the flap suture presents risk of exposure (fine model); space making in gingival recessions (fine model). Handling The membrane can be shaped with sterile scissors until the desired size is reached; it must then be rehydrated with lukewarm physiological solution. N.B: in case of accidental exposure, the dense collagenic matrix of Evolution protects the graft from infection; the membrane itself will not be infected, facilitating second intention healing. Derma Tissue of origin Porcine derma. Tissue collagen Preserved. Physical form Dried membrane. Composition 100% derma. Tickness Fine: 1mm. Standard: 2mm. Estimated resorption time Fine: about 3 months. Standard: about 4 months. Packaging Fine: 25x25mm; 50x50mm. Standard: 30x30mm; 50x50mm. Clinical applications Oral Surgery and Traumatology: stabilization and protection of large regenerations with risk of exposure. Implantology: protection of two-wall defects grafts. Periodontology: space making in gingival recessions (fine model). Handling The membrane can be shaped with sterile scissors until the desired size is reached; it must then be hydrated for 15 minutes with lukewarm physiological solution. It is always recommendable to prepare a pocket with a periosteal elevator in order to ensure that the membrane closes properly after stitching the flaps. SEE OTHER AVAILABLE BIOMATERIALS 10

BONE REGENERATION TACK FIXING DEVICES STRAIGHT TACK HOLDER Used to secure membranes over surgical grafted sites with tacks. PN-IMTA www.microdentsystem.com Made of stainless steel. To place a tack, gently tap the tack holder with the mallet. To remove a tack, insert an MH090 screwdriver into the hexagon carved on the tack head. ANGLED TACK HOLDER Used to secure membranes over surgical grafted sites with tacks. PN-IATA Made of stainless steel To place a tack, gently tap the tack holder with the mallet. To remove a tack, insert an MH090 screwdriver into the hexagon carved on the tack head. Screwdriver PN-MH090 MALLET Used to hit directly the tack holder and place the tacks. PN-MTQP MALLET ALSO AVAILABLE MADE ENTIRELY OF STAINLESS STEEL Made of stainless steel and POM. TACKS Made of titanium. Available in two different lengths: 3mm and 5mm, the latter adonised in blue to identify the difference in length. To place a tack into the recipient site, grip the tack with the tack holder and then tap it with the mallet. To remove a tack, insert an MH090 screwdriver into the hexagon carved on the tack head. TA03 TA05 Bone regeneration catalogue 11

BONE REGENERATION MEMBRANE FIXING KIT Surgical kit containing the necessary surgical instruments to fix membranes and grafting material. Content of the kit: Straight tack holder to place tacks. Angled tack holder to place tacks. Mallet. Tack organizer with 3mm and 5mm tacks, colour-coded for easier identification. PN-KFM Removable tack organizer for easier use. Also available separately (PN-COCV). 12

BONE REGENERATION OSTEOSYNTHESIS SCREWS OSTEOSYNTHESIS SCREWS Available in different diameters and lengths, colour-coded for easy identification. Made of titanium. With a cross-slotted head. Place with a manual screwdriver or with contra angle screwdriver. www.microdentsystem.com Height Ø 1.20mm Ø 1.50mm Ø 2.00mm h= 4 h= 6 h= 8 TO1204 TO1206 TO1208 TO1504 TO1506 TO1508 TO2004 TO2006 TO2008 Thanks to PN-TODTCM (manual) and PN- TODTCC (for contra angle) cross-slotted screwdrivers, osteosynthesis screws are easily carried to the placement site and properly placed. These screwdrivers enable an uncomplicated use of the osteosynthesis screws. h= 10 TO1210 TO1510 TO2010 h= 12 TO1212 h= 14 - TO1512 TO1514 TO2012 TO2014 Ø 1.20mm Ø 1.50mm Ø 2.00mm DRILL Ø 1.00mm For fixing Ø 1.20mm osteosynthesis screws. Colour-coded in blue. DRILL Ø 1.30mm For fixing Ø 1.50mm osteosynthesis screws. Colour-coded in purple. DRILL Ø 1.60mm For fixing Ø 2.00mm osteosynthesis screws. Colour-coded in green. F100 F1312 F1614 Made of stainless steel. Bone regeneration catalogue 13

BONE REGENERATION OSTEOSYNTHESIS FIXING SCREWS MANUAL SCREWDRIVER HANDLE Used to insert the appropriate screwdriver to place osteosynthesis screws. PN-MIADTM MANUAL SCREWDRIVER To be inserted into the manual handle. With a cross-sloted tip. PN-TODTCM Made of stainless steel. Cross-slotted head. To be inserted into the manual handle. CONTRA ANGLE SCREWDRIVER Screwdriver for easy handling of osteosynthesis screws. PN-TODTCC Made of stainless steel. Cross-slotted head. Used with a motor. COUNTERSINK DRILL Used to ensure that the screw head does not protude. PN-FCTO Made of stainless steel. DRILL Ø 2.10mm Used to enable the screw to pass through the block to be threaded into the bone. PN-F2108 Made of stainless steel. 14

BONE REGENERATION OSTEOSYNTHESIS SCREW FIXING KIT Osteosynthesis screw surgical kit with the appropriate instruments to fix bone blocks in oral and maxillofacial surgery. Content of the kit : Manual screwdriver handle. Manual screwdriver. Contra angle screwdriver. Countersink drill. Drills of 1.00mm, 1.30mm, 1.60mm and 2.10mm. Screw organizer for screws with diameter: 1.20mm, 1.50mm and 2.00mm with lengths from 4 to 14mm. www.microdentsystem.com PN-KIO Removable screw organizer for easier use. (With capacity for 48 screws) Also available separately (PN-COTV). Bone regeneration catalogue 15

BONE REGENERATION TREPHINE DRILLS FOR BONE EXTRACTION As their name indicates and due to their design, these trephine drills maintain control and display the portion of bone to be removed. TF35 TF50 TF60 Ø Inside Ø Outside Ø Inside Ø Outside Ø Inside Ø Outside 2.50mm 3.50mm 4.00mm 5.00mm 5.00mm 6.00mm Ø In. 2.50mm Ø Out. 3.50mm Ø In. 4.00mm Ø Out. 5.00mm Ø In. 5.00mm Ø Out. 6.00mm 16

www.microdentsystem.com BONE REGENERATION CLINICAL CASES Bone regeneration catalogue 17

CLINICAL CASE Nº1 Clinical case by Dr. Holmes Ortega Mejía. 24-year-old patient with tooth 1.2 missing and grade III tooth mobility, teeth 1.1, 1.2, 2.1 and 2.2 are loose. Creation of a full thickness flap and extraction of mobile teeth. Perforation of vestibular plate. Microdent membrane fixing kit. Placing of an Evolution membrane fixed with Microdent tacks. Placing of Apatos bone with PRGF. Placement of two tacks on the palatine side to fix the graft. Stitching with monofilament 4/0 sutures. Scan at 4 months. Scan at 4 months. Note the significant improvement in the bone volume at 5 months. 18

CLINICAL CASE Nº2 Clinical case by Dr. Holmes Ortega Mejía. www.microdentsystem.com 47-year-old patient with teeth extracted 20 years ago. Crestal lingual incision. Crest with 2mm thickness. Longitudinal corticotomy. Sequence of Microdent expanders. Drilling of vestibular plate after the expansion. Placing of Ø 1.20mm Microdent osteosynthesis screws (blue colour). Note the lingual plate fracture. Placing of two osteosynthesis screws to maintain the gained space. Placing of a membrane on the lingual side and securing with sutures. Filling up with Apatos bone and fixing with Microdent tacks. Observe on the orthopantomography 2 osteosynthesis screws and 2 tacks, both pertaining to the Microdent brand. Observe on the scan slices the evolution of the bone volume. Bone regeneration catalogue 19

CLINICAL CASE Nº3 Clinical case by Dr. Holmes Ortega Mejía 47-year-old patient with tooth mobility issues, three superior incisor teeth are loose. Low upper labial frenulum. Upper labial frenulum could affect the regeneration. Periodontal probing of 9mm. Cut of the upper labial frenulum. Stitching of the upper labial frenulum to the bottom of the vestibule. Full tickness flap. Note the granulation tissue. Extraction of tooth 1.2. Cleaning of the granulation tissue. Bone defect, 9mm wide and 6mm high. Extraction of teeth 1.1 and 2.2. Cleaning of the granulation tissue. Cut of an Evolution membrane for the lateral to the nasopalatine nerve. Stitching with matress sutures to hold the membrane. 20

www.microdentsystem.com Placing of the Evolution membrane. Placing of the corticalized membrane (soft) and fixing with Microdent tacks. Biological drilling. Placing of Ø 4x12mm Ektos implants. Bone regeneration with Apatos bone. Fixing of the membrane on the crestal side with Microdent tacks. Overlapping of the Evolution membrane and fixing with Microdent tacks on the vestibular side. Stitching with simple retention acid poliglycolic sutures. Protection of the cuts with Periacryl (cyanocrylate-based adhesive) to strengthen the sutures and protect the soft tissues. Observe on the scan slices the transverse bone defect involving the vestibular and palatine plate. Observe on the orthopantomography the localized periodontal disease. Bone regeneration catalogue 21

CLINICAL CASE Nº4 Clinical case by Dr. Antonio Murillo Rodríguez. Female patient with no significant medical history goes to the clinic to replace missing teeth in the third quadrant. A clinical and radiological examination are performed. There is loss of bone in 3.3 that will need to be regenerated before proceeding to the placement of the implant. Initial physical appearance. Bone defect in zone 3.4. It is necessary to regenerate the zone previously in order to later place the implants. Placing of a membrane apically and fixing with osteosynthesis screws. Detail of the screw once it has been placed. Detail of the membrane once it has been placed. Stitching of the flap with 5/0 monofilament sutures. 22

GENERAL CONDITIONS Customer service Tel. 0034-93 844 76 50 from Monday Thursday: 9h-18h and Friday: 8h-15h. Purchase order Tel. 0034-93 844 76 50, extension 1. Fax: 0034-93 844 76 93. E-mail: implant@microdentsystem.com. Webpage: www.microdentsystem.com. Delivery times Peninsula: Orders placed before 14h will be delivered on the next business day. Canary Islands: Orders placed before 14h will be delivered on the next 24-48 h. Province of Barcelona: consult about same day deliveries. * For deliveries outside Spain, please contact us. Shipping policy The following shipment methods are available for orders placed before 14h: Service 8.30 Priority: delivery between 8.30h and 10h. Express: delivery between 10h and 13h. Service 19h: delivery before 19h. Urgent: delivery time out of the established timetable (in the evening) has an extra charge. * Available for the Peninsula (for Canary Islands, please contact us). * For deliveries outside Spain, please contact us. Product return policy All returns must be accompanied by the return form, duly completed, and a copy of the delivery note. Any returns or refunds of items that have been opened, tampered with or not in their original condition will not be accepted. Billing and payment methods Ask our customer service or your local representative about different payment plan options. * Microdent reserves the right to improve, modify or discontinue products and equipment at any time without incurring any obligation or without prior notice. * For commercial schedules and deliveries outside Spain, please ask about conditions by country. Important The use of foreign-brand surgical instruments may compromise the stability and fixation of the prosthesis, as well as cause situations of loosening or fracture. Moreover, it also voids the product warranty. Design and layout 2016

Edition: June 2016 (Spain)