Dentsply Sirona
TempDesign Profile EV and Temp Abutment Profile EV
2 Pages
Preview
Page 1
Instructions for Use
Astra Tech Implant System® TempDesign™ Profile EV/Temp Abutment Profile EV CAUTION: US federal law restricts this product to sale by or on order of a dentist or a physician. Astra Tech Implant System EV may only be used by dentists/physicians who have had the appropriate education and training.
Description of the System The system comprises dental implants, cover screws, transmucosal abutments, other prosthetic components, as well as surgical and prosthetic instruments. Astra Tech Implant System EV components may only be used together with original products and instruments. The Astra Tech Implant System EV assortment is designed to simplify the use of correct components by means of markings, color coding and/or geometrical design.
Description of the Product TempDesign Profile EV/Temp Abutment Profile EV are two-piece temporary components indicated for screw and cement-retained restorations offering the possibility to design a customized abutment for individual requirements using grinders and cutting equipment and add on materials e.g. acrylic and composites. The temporary abutments have a conical connection to the implant, which enables a tight and stable fit between the components – Conical Seal Design. TempDesign Profile EV/Temp Abutment Profile EV have a One-position-only placement in the implant. The plastic part of the TempDesign Profile EV is designed with the flexibility of customization for individual requirements. The abutment screws for the temporary abutments are color coded according to implant sizes.
Ordering Information and Dimensions See current product catalog for updated and detailed order information of the various TempDesign Profile EV/Temp Abutment Profile EV.
Material Titanium Alloy Grade 5 Plastic
Indications for use Astra Tech Implant System EV abutments are intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches.
Contraindications There are no absolute contraindications for treatment with Astra Tech Implant System implants besides the ones applicable for implant treatment in general.
Clinical Application TempDesign Profile EV/Temp Abutment Profile EV are intended for: ● Temporary cement-retained restorations in single, partial and fully edentulous situations in all positions in the mouth in immediate, early and delayed loading situations. ● Temporary one-piece screw-retained single restoration in all positions in the mouth in immediate, early and delayed loading situations. ● The abutments are used for creating/providing different shapes and designs for optimizing soft tissue sculpturing.
For Instructions for Use and symbols glossary refer to ifu.dentsplysirona.com
Precautions NOTE: Recommended for clinical use up to 180 days. Components and instruments for Astra Tech Implant System are not compatible with Astra Tech Implant System EV. The TempDesign Profile EV/Temp Abutment Profile EV should only be used with OsseoSpeed Profile EV. Fracture of mandible may occur in a very atrophic mandible, during surgery or during routine oral function after surgery. Highly angled abutments on small diameter implants are not recommended for use in the molar region. Routine implant treatment is not recommended until the end of the jaw bone growth. Implant, prosthetic component or prosthesis fracture may occur due to unfavorable loading conditions. Mastication forces and restoration design have to be evaluated carefully. Inadequate cooling, incorrect implant site preparation, incorrect instrument settings or excessive installation torque can result in failed implant. Bone quality and quantity, local infections or disturbed initial healing are all factors, which may influence implant survival. Successful healing and osseointegration may be negatively affected by the following factors: ● compromised general health status ● compromised local health status in the jaws ● history of therapeutic radiation in the area ● alcohol or drug abuse ● smoking
MRI Safety Information The TempDesign Profile EV/Temp Abutment Profile EV have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. The safety of TempDesign Profile EV/Temp Abutment Profile EV in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Adverse Reactions During implant treatment, possible adverse reactions may include but are not limited to: ● Allergy (e.g. anaphylactic shock) ● Uncontrolled post-operative bleeding (e.g. damage to arteria lingualis) ● Aspirated or swallowed components ● Permanent nerve injury ● Fractured mandible ● Implant loss ● Peri-implantitis ● Component or prosthesis failure/fracture
Step-by-Step Instructions ● ● ●
Try-in the temporary abutment on a working model or do the temporization “chair-side” immediately. Always use the laboratory abutment screw for non-clinical use on the working model. When installing or removing the component, make sure there is a sufficient carrying function before picking up the component.
Warnings
For Screw-Retained Crown
Surgery in the oral cavity and oral rehabilitation include general risks for complications which should be known by the clinician. To be mentioned, but not limited to, the following: ● Components that accidently are dropped in the patient’s mouth may be swallowed or aspirated which can result in suffocation or physical injury. Care must be taken to have control over small devices. ● Allergy or hypersensitivity to chemical ingredients of material used. Patient health history must be carefully assessed. ● Failure to plan and prepare implant site position and depth correctly can result in harm to nerves, blood vessels, teeth or other sensitive structures. It is strongly recommended that clinicians always undergo special training before starting up new treatment methods.
●
Design the abutment to function as retentive base for the composite/acrylic. Build up the crown structure on the abutment. Keep screw access hole open by using a Lab Pin Design EV. NOTE: The plastic part of TempDesign Profile EV bonds only mechanically to dental acrylics and composite.
●
● ●
Make sure not to damage the implant interface part of the abutment during modification of the abutment. A general recommendation is to stop reducing on the abutment 1 mm above the implant interface and avoid radical changes in that area. Clean and/or sterilize all the components (see section Cleaning and sterilization). Perform a try-in.
Subject to change without prior notice.
Manufacturer: Dentsply Implants Manufacturing GmbH Rodenbacher Chaussee 4, 63457 Hanau, Germany www.dentsplyimplants.com www.dentsplysirona.com
Not all products are available in all countries.
Status of information: IFU 5927-en_US Rev. 002 A 2023-11
1 (2)
Instructions for Use ● ● ● ●
To prevent mist and possible leakage into the implant connection, make sure the component is situated all the way down into the interface indexing. Always use a pristine abutment screw in any clinical situation. Use the Restorative Driver Handle EV together with the Hex Driver EV and Torque Wrench EV to tighten to the recommended torque. Cover the screw head before the screw channel is filled with a suitable material.
Trademarks All trademarks and company names are the property of their respective owners. To improve readability for our customers, Dentsply Sirona Implants does not use ® or ™ in body copy. However, Dentsply Sirona Implants does not waive any right to the trademark and nothing herein shall be interpreted to the contrary.
For Cement-Retained Restoration ●
Cement the temporary acrylic built-in crown onto the abutment or use a prefabricated tooth and carefully remove all excess cement. ● The supra construction should have a passive fit on the abutment to prevent tension in the implant restoration. For detailed information see latest version of appropriate manuals.
Recommended tightening torque for temporary installation is 15 Ncm.
Cleaning and Sterilization The abutment and abutment screw are delivered non-sterile. Before installation, the non-sterile abutments and abutment screws must be cleaned and sterilized.
Manual Procedure Apply detergent, neodisher® MediClean forte (Dr. Weigert, Hamburg) or similar solution to all surfaces. Scrub the outer and, if applicable, the inner side of the product with a soft bristled nylon brush until all visible soil and/or debris is removed. Flush the inner channels/lumen with cleaning solution using an irrigation needle connected to a syringe. Check channels/lumen for residual soil and/or debris. Run the products in an ultra-sonic bath with cleaning solution for minimum ten minutes. Drills and trays excluded. Rinse under clean running water until all trace of cleaning solution is removed. Flush the inner channels/lumen with water using an irrigation needle. Prepare a bath with a disinfection solution, ID 212 instrument disinfection (DÜRR SYSTEM-HYGIENE) or similar, according to the detergent manufacturer’s instruction. Immerse the products completely for the time specified by the manufacturer. Flush minimum 3 times internal channels/lumen using an irrigation needle. Rinse under clean running water until all trace of disinfection solution is removed. Flush the inner channels/lumen with water using an irrigation needle. Dry the products using medical compressed air and clean lint-free single-use wipes.
Automated Procedure Place instruments in a washer-disinfector, Vario TD or similar, according to recommendations from the supplier: Example of Vario TD washing program: ● Pre-wash, 20 °C ● Cleaning with detergent, neodisher® MediClean forte (Dr. Weigert, Hamburg) or similar solution 45-55 °C ● Neutralization ● Intermediate rinse ● Disinfection, > 90 °C (preferably 93 °C), 5 min ● Drying
Packaging prior to Sterilization Thoroughly dry everything prior to the sterilization process to prevent the risk of corrosion. It is recommended to place the abutments, screws, and applicable products in a sterilization bag. NOTE: For US: Use FDA cleared sterilization bag and 16 minutes dry time at the end of the steam sterilization cycle.
Sterilization Steam sterilization with a pre-vacuum cycle (134 °C for 3 minutes). NOTE: For US: Steam sterilization with a pre-vacuum cycle (275 °F for 3 minutes). Use the sterilized components within stated time period from sterile bag manufacturer.
Package and Storage The products are for single use. The temporary abutments are packed together with an abutment screw. The components must be stored, in their sealed package, in a dry place, at normal room temperature i.e. 18-25 °C/64-77 °F.
Documentation To ensure traceability, we recommend that the removable label on the package be attached to the patient record.
Subject to change without prior notice.
Manufacturer: Dentsply Implants Manufacturing GmbH Rodenbacher Chaussee 4, 63457 Hanau, Germany www.dentsplyimplants.com www.dentsplysirona.com
Not all products are available in all countries.
Status of information: IFU 5927-en_US Rev. 002 A 2023-11
2 (2)