PRODUCT INFORMATION FOR CORTEX ABUTMENTS AND OTHER RESTORATIVE COMPONENTS

Transcription

1 PRODUCT INFORMATION FOR CORTEX ABUTMENTS AND OTHER RESTORATIVE COMPONENTS The Cortex Implants are intended for single or multiple replacements of lost teeth and provide a way to attach the prosthetic pieces in totally or partially edentulous patients. This document applies to all Cortex dental implant abutments and overdenture bar/frameworks. Description: Cortex Dental Implant Abutments and Overdenture Bars and/or Frameworks are manufactured from biocompatible materials (including titanium alloy and PEEK polyether-ether-ketone). Cortex Implant Abutments may have various treatments such as titanium nitride and anodized surfaces and/or coatings. Indications for Use: Surgeons and all practitioners should be fully trained in such procedures and be competent in such implant practices. All practitioners should attend courses of study to familiarize themselves with implantology techniques. Improper technique can cause bone loss and implant failure. Cortex Dental Implant Abutments, Overdenture Bars and/or Frameworks are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially edentulous or edentulous patient. These are intended for use to support single- and multiple-tooth prostheses in the jaws. Contrindications: Do not use these components if the patient has a known hypersensitivity to titanium, titanium alloy, ceramic materials, or PEEK. The system is not for use with limited inter-occlusal space less than 7.0mm. It is not for use when implants are divergent greater than 45 with the 30 Angled Abutment or when implants are divergent greater than 30 with the 15 Angled Abutment. The Angled Abutment may not be excessively prepped. Severe bruxism, clenching, and overloading, may cause bone loss, screw loosening, component fracture, and/or implant failure.

2 Instructions for Use Plastic/Titanium Abutments UCLA Plastic/Titanium abutments are made out of titanium alloy base and burn out cylinder, creating a very strong bond to cast Precious metals or Semi-Precious metal alloys. The titanium alloy is not a porcelain-bonding alloy. The alloy is designed to have oxidation during casting-on procedures. Do not bond porcelain directly to the titanium base. This could result in the porcelain going slightly green or chipping of due to a poor bond. The melting temperature of the titanium alloy is approx C. Labs cast at approx. 920 C. Warning: Grinding or adjusting the metal prior to casting will cause significant damage to the abutment during the casting process. Use only alloys with casting temperature below 1140 degrees C. Do not use any solutions to remove investment material after casting. These solutions can attack the titanium alloy and can damage the abutment. Instead use light bead blasting. 1. Wax UCLA abutment in usual fashion. Once waxing is complete, take an ear bud and clean fitting surface of the titanium base to remove any wax residue. Set burnout temperature at maximum 760 C starting around 180 C for 15 min. Keep ring at burnout temperature for ONE HOUR MAXIMUM. Do not overheat metal and rings as it will create porosity on the titanium bases. Only use a high noble or semi-precious crown and bridge alloy. Do not use non-precious alloys. Cast in the same fashion as regular gold alloys. Once the cast metal has been oxidized, it needs to be sandblasted before applying opaque. For removal of investment residue use dry glass beads only and steam the casting (NO DEGASSING or PICKLING WITH ANY SOLUTION). The seating surface of the titanium base should be blocked out with a thin layer of wax or by attaching a laboratory analogue, to avoid any damage during the blasting procedure. 11. Apply low fusing or medium fusing Ceramic to the abutment. 12. The final temperature of 748 C should be kept for only one minute.

3 Instructions for Use Plastic/Cobalt Chrome (CoCr) UCLA Abutment UCLA Plastic/CoCr abutments are made out of CoCr alloy base and burn out cylinder, creating a very strong bond to cast different metal alloys. CoCr UCLA Abutments are designed for use with Cortex implants to provide support and retention for multi-unit (splinted) screw-retained restorations in the mandible or maxilla. The system consists of the abutment, abutment screw, and a plastic modeling aid. The CoCr abutment is packaged together with an abutment screw to allow the clinician to have the components required for clinical use. The abutments are manufactured from CoCr material which conforms to ISO and ASTM F and the abutment screw is manufactured from titanium alloy (Ti 6AI-4V ELI) which conforms to ASTM F136. Contraindications: Do not use in cases of hypersensitivity to one or more of the metals contained in the alloy. The potential exists for allergies to the metals contained in the alloy. Interactions: Avoid occlusal and approx. contact between different alloy types. Technical data: Chemical composition (mass-%): 66% Co; 28% Cr; 6% Mo; (<1% Nickel) Soldering: Cortex recommends a low Nickel, Cobalt Chromium Molybdenum alloy for repair and connection soldering of the CoCr alloy. Never use a gold or palladium solder with cobalt/chromium alloys Place the CoCr Abutment on the master model. The plastic sleeve can be used while sculpturing the tooth. Reduce the chimney of the CoCr Abutment so that it is out of occlusion with the plastic sleeve in place. Casting: Use cobalt/chromium alloys and propane/oxygen or acetylene/oxygen Make sure the bridge fits passively on the implants. For fastening, use titanium abutment screws and the driver together with the torque wrench and tighten to 30Ncm.

4 Cortex Ti Bases Product description: Ti-Base and Abutment Screw are used for the digital acquisition of an implant position and for the prosthetic restoration implants. In digital process, a Scan-Body (product name Scan-body) optically acquired for transmission the implant position to a model. For this purpose, a titanium base (product name: Ti-Base) is mounted on an implant or laboratory analog with an Abutment Screw (product name: Abutment Screw) and a suitable Scan-body is connected to this. The titanium base is designed on the bottom side in line with the implant s specific connection and can only be screwed onto specific implants with a certain platform connection. The top side is formed for the acquisition of a prosthetic restoration. A titanium base can also be used for the prosthetic restoration of an implant. For this purpose, a mesostructure is cemented onto the titanium base. Depending on the mesostructured design, the product cemented to the titanium base can be used as the abutment or directly screw retained crown or bridge. An Abutment Screw is also used for the definitive attachment to the implant. The Ti-Base product comprises two individual components: Titanium base and Abutment Screw. The Abutment Screw product comprises two identical Abutment Screws. Abutment Screws are provided within the Ti-Bases. Instruction for use Indication: For manufacturing of individual abutments on dental implants. The individual abutments can be combined with copings, crowns or supra-structures made of dental ceramics. Contrindication: Insufficient oral hygiene Insufficient space available Bruxisme For restorations with angulation correction of more than 20 to the implant axis For individual tooth restorations with free end saddle For restorations whose length exceeds a ratio of 1:1.25 in comparison to the length of the implant. The Ti-bases of each Connection can only be combined with the matching implant, Hexagonal, Conical NP, RP and WP. They cannot be combined with implants of a different implant type or manufacturer. The diameter of the Tibase must correspond in size to the used implant in order to prevent a peri-implant tissue irritation. The Ti-bases are indicated for single use only. If they are used multiple times, they might damage the implants.

5 For fixation of the Ti-bases on the implant, the correct torque force, recommended by the implant manufacturer, has to be considered carefully to avoid the damage of the implant-bone connection. Mechanical treatment of the connection part of the Ti-base will damage the correct fitting of the Ti-base on the implant. Handling method: Ceramic abutments: Milling with CAD/CAM-machines of zirconium oxide- or aluminum oxide- ceramics according to the anatomic form of a crown or coping. The ceramic copings or crowns shall be milled or polished with diamond instruments and with minimal pressure and water- cooling. The minimal thickness shall be 0.5 mm Sharpe edges must be avoided. Veneering: Copings shall be veneered with appropriate ceramics before cementing onto the ti-base. The instructions for use of the ceramic manufacturers have to be considered. Treatment of the Ti-base and the ceramic abutment before cementing: Sandblasting of the contact surfaces with Al2O3, 50μm, 2 bar and intensive cleaning of dust and grease. It is recommended to protect the connection part of the Ti-base with an implant analog during handling. Cementing: It is recommended to cement the ceramic abutment onto the Ti- base with panavia F2.0 (Kuraray) with RelayXUnicem (3M Espe), Multilink. Hybrid Abutment (Ivoclar Vivadent) or other equivalent cements. The instructions for use of the cements shall be followed carefully. The Ti-base shall be fixed onto an implant analog with the abutments screw. The head of the screw has to be covered with wax or resin. The mixed cement is applied onto the contact part of the Ti-base. The abutment is pressed onto the Ti-base. The final position is evaluated by slight rotation. The gap between abutment and the Ti-base must be as small as possible. Remaining cement shall be removed immediately. Polishing: After hardening the remaining cement shall be removed with rotating silicon instruments. The cement inside the screw channel has to be removed carefully. The titanium bases Ti-Bases are delivered in non-sterile condition. Observe the implant manufacturer's operating instructions.

6 Scan body Indication: Scan body: For the CAD/CAM scanning of the model, the Scan body is used to indicate the position of the implant. The size of the Scan body shall be corresponding to the original Implant system, implant diameter and Ti-base Series. The chamfer of the Scan body prevents the rotation of the ceramic abutment. The Scan body is fixed on the implant analogue with the abutment screw. After correct positioning, there is no gap visible between implant and Scan body. Rotation of the Scan body is impossible.

7 Storage and Handling: The components should be stored at room temperature. Refer to individual product labels and the Restorative Manual for special storage or handling conditions, if any. Sterility: Some components are supplied sterile. Refer to individual product labels for sterilization information; all sterile products are labeled STERILE. All products sold sterile are for single use before the expiration date printed on the product label. Do not use sterile products if the packaging has been damaged or previously opened. Instructions for Cortex Restorative Components Requiring Sterilization before Use: Products provided non-sterile must be sterilized prior to use. Cleaning and sterilization: Instructions for Cortex Restorative Components Requiring Cleaning and Sterilization before Use. Products provided non-sterile must be cleaned and sterilized prior to use. Cleaning: 1. Prepare a neutral/mild ph enzymatic detergent, according to manufacturer s instructions. 2. Soak the products in the enzymatic detergent for 20 minutes or until cleaning can be performed. 3. While the products are submersed, use a nylon brush to clean the surface of the product. 4. After the immersion period, remove the products from the enzyme solution and rinse them thoroughly under hard stream of tap water for at least 1 minute. 5. Leave the products to complete air dry for at least 5 minutes. The cleaning process will be conducted using Enzymatic Detergent according to the Local regulation. Sterilization: Use steam gravity sterilization: 30 minutes at a temperature of 250 F (121 C), drying time of minutes or 10 minutes at a temperature of 275 F (135 C), drying time of 30 minutes. Drying times may vary according to load size. Do not re-sterilize or autoclave components except where instructions are provided on the product label, the Restorative Manual, or in any additional product literature for the given component. Warnings: Handling of small components inside the patients mouth carries a risk of ingestion and/or aspiration. When restorative components are loaded beyond their capacity, breakage may occur. It is recommended that small diameter implants not be restored with angled abutments in the posterior region. It is recommended to be placed in the anterior region of the mouth. PEEK components are intended for use to support single- or multiple- unit provisional prostheses in the mandible or maxilla for up to 180 days, at which time a definitive prosthesis should be inserted. Reuse of Cortex products that are labeled for single-use may result in product contamination, patient infection and/or failure of the device to perform as intended.

8 Cortex Dental Implant Abutments have not been evaluated for safety and compatibility in the Magnetic Resonance Imaging environment. Cortex Dental Implant Abutments have not been tested for heating or migration in the Magnetic Resonance Imaging environment. Precautions: For safe and effective use of Cortex Dental Implant Abutments and other surgical and restorative dental accessories, these products or devices should only be used by trained professionals. The surgical and restorative techniques required to properly utilize these devices are highly specialized and complex procedures. Improper technique or overloading can lead to implant failure, loss of supporting bone, restoration fracture, screw loosening and/or aspiration. Excessive forces applied to the dental implant should be avoided. Proper occlusion of the restoration should be evaluated and the patient s para-functional habits should be taken into consideration. Potential Adverse Events: Potential adverse events associated with the use of restorative components may include: Infection or mucosal inflammation due to poor maintenance and cleaning of the components Excessive bone loss requiring intervention Implant or component failure Choking from aspiration of components For detailed information on the specific procedure for the product being used, please refer to the individual product labels and/or the appropriate manual. Caution: U.S. Federal Law restricts this device to sale by or on the order of a licensed dentist or physician. Prosthetic Platform Torque Hexagonal Conical NP Conical RP Conical WP Torque 30 Ncm 20 Ncm 30 Ncm 35 Ncm Manufactured by: CORTEX Dental Implants Industries Ltd. Israel Industrial Zone Shlomi, Ya'ara st. 26, P.O. Box 125, Israel Tel: / Fax: info@cortex-dental.com Update date: