Dentsply Sirona
Astra Tech Implant System EV Repair Instruments Instructions for Use
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Instructions for Use
Astra Tech Implant System® EV Repair Instruments Description of the System The Astra Tech Implant System EV assortment comprises dental implants, cover screws, transmucosal abutments, other prosthetic components, as well as surgical and prosthetic instruments.
For Instructions for Use and symbols glossary refer to ifu.dentsplysirona.com
Uni Abutment Retriever The Uni Abutment Retriever is used for removal of Uni Abutments with damaged internal threads or for removal of damaged Uni Abutments in TX implants or implants carrying the EV connection.
Intended Users Users must be licensed dentists/physicians, be trained in implant dentistry and should be familiar with Astra Tech Implant System EV.
Indications
Clinical Benefit and Patient Target Group The Astra Tech Implant System EV is designed for replacing one or more missing teeth in patients to restore chewing function. The patient target group are persons with adult jaws to whom none of the contraindications apply that are related to dental implantations.
Contraindications
Compatibility The products are compatible with the Astra Tech Implant System EV assortment and the implant assortment of DS Implants carrying the EV connection (see table below for details). The components may only be used together with original products and instruments. All instruments which can be used in combination with a contra-angle handpiece have an RA/CA-connection according to ISO 1797 or are compatible with ISO 1797. Compatibility
Complications after implant treatment of partial and total edentulism
Allergic or hypersensitivity reactions to materials used (see section “Material”)
Warnings Surgery in the oral cavity and oral rehabilitation include general risks for complications: ● The lege artis restoration of the implant may not be possible because of damage at the implant interface, and the implant must be explanted. ● The preparation of the thread may not be possible and therefore the prosthetic restoration cannot be preserved. ● Components that accidently are dropped in the patient’s mouth may be swallowed or aspirated which can result in damage to the digestive/respiratory system or dyspnea. Care must be taken to have control over small devices. ● Necessity of explantation of the implant after breakage of instruments and associated damage to anatomical structures ● Slipping of instruments which may damage the surrounding structures ● Jammed/broken instruments
Astra Tech Implant System EV
PrimeTaper EV
OmniTaper EV
Guiding Cylinder EV
Yes
Yes
Yes
Fragment Fork
Yes
Yes
Yes
Precautions
Screw Extractor
Yes
Yes
Yes
●
Thread Cleaner
Yes
Yes
Yes
Fragment Drills
Yes
Yes
Yes
Trephine Drills
Yes
Yes
No
Implant Retriever
Yes
Yes
Yes
Product
Intended Use
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The Repair Instruments are used to remove screw fragments in the implant/abutment or to remove the implant/abutment. Guiding Cylinder EV The Guiding Cylinder EV is used in combination with the Guiding Cylinder Handle to guide the instruments into the center of the abutment screw fragment in the implant. Guiding Cylinder Uni Abutment EV The Guiding Cylinder Uni Abutment EV is used in combination with the Guiding Cylinder Handle to guide the instruments into the center of the bridge screw fragment in the Uni Abutment EV. Guiding Cylinder Handle The Guiding Cylinder Handle is an adjustable handle for the Guiding Cylinders. Fragment Fork The Fragment Fork is used for removal of abutment screw fragments and bridge screw fragments. Screw Extractor The Screw Extractor is used for removal of abutment screw fragments. Thread Cleaner The Thread Cleaner is used for cleaning of threads internally in an implant/abutment. Fragment Drills The Fragment Drill is used for creating an indentation in the abutment screw/bridge screw fragment. Implant Retriever The Implant Retriever is used for removal of damaged implants or implants with damaged internal threads. Trephine Drills The Trephine Drill is used for removal of partly or fully osseointegrated implants. Rescue Driver Uni Abutment EV The Rescue Driver Uni Abutment EV is used for removal of the Uni Abutment EV.
● ● ● ● ● ● ● ●
Prior to each procedure it must be ensured that all necessary components, instruments and materials are available in the required quantities and are fully operational. Position the patient so that the danger of aspiration of components is minimized. All components that are used intraorally must be secured to prevent aspiration or swallowing. During preparation with drills the recommended speed, which is in the range of the maximum speed, must be used. The maximum speed must not be exceeded and also the speed must not be reduced to an excessively slow level. Fracture of mandible may occur in a very atrophic mandible, during surgery or during routine oral function after surgery. If, due to unfavorable anatomical conditions, instruments do not fit or cannot be used for other reasons, the course of treatment planned with them must not be continued and alternatives must be sought. All products intended for single use must not be re-used. Failure to observe this precaution may cause a loss of accuracy and precision of the instruments through to fractures of the instruments. Products intended for manual use shall not be used together with a contraangle handpiece. Schedule sufficient time for careful use of the repair instruments. Adequate space should be ensured around the implant to be repaired. Replace dull drills immediately. Where the repair is not successful (e.g. breakage of an instrument), a trephine drill adjusted to the diameter of the implant should be kept ready for explantation of the implant.
Adverse Reactions Adverse reactions during or after the treatment can be: ● Allergic or hypersensitivity reactions to materials used (see section “Material”) ● Damage to the digestive/respiratory system or dyspnea as a consequence of aspirated or swallowed components ● Permanent harm to nerve or tooth ● Harm to jawbone or maxillary sinus ● Necrosis due to inadequate cooling or excessive torque ● Fractured mandible ● Uncontrolled post-operative bleeding (e.g., damage to arteria lingualis) ● Post-operative discomfort such as: ▪ Edema ▪ Hematoma ▪ Temporary local swelling Subject to change without prior notice. Other languages are available upon request.
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 5979-EN Rev. 001 A 2022-09
1 (5)
Instructions for Use
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▪ Temporary anesthesia or paresthesia and masticatory impediment ▪ Pain Implant loss Local or systemic infection Fracture or damage of implants Esthetic or functional complications
MRI Safety Information
Instruments to remove implants
The Implant Retriever is used for removal of damaged implants or implants with damaged internal threads.
Not applicable for the Repair Instruments.
Step-by-Step Instructions
The Trephine Drill is used for the removal of partly or fully osseointegrated implants.
Description of the Repair Instruments Instrument
Max. Speed Max. Torque
Instruments to remove screw fragments The Guiding Cylinder EV is used to guide the instruments into the center of the abutment screw fragment and protects the internal threads in the implant.
The Trephine Drills are marked according to the implant size. The drills are marked with diameter and length. The drills have depth markings of the respective implant lengths and are available in in short (6–13 mm) and long (6–17 mm).
300 rpm
Instruments to remove abutments
The cylinders are marked with diameter and EV. The Guiding Cylinder Uni Abutment EV is used to guide the instruments into the center of the bridge screw fragment in the Uni Abutment EV.
The Rescue Driver Uni Abutment EV is used for the removal of a Uni Abutment EV.
The cylinders are marked with Uni and EV. The Guiding Cylinder Handle is an adjustable handle for the Guiding Cylinders.
The Uni Abutment Retriever is used for removal of Uni Abutments with damaged internal threads or for removal of damaged Uni Abutments in TX implants or implants carrying the EV connection.
The Fragment Fork is used for the removal of abutment screw fragments and bridge screw fragments.
Abutment screw fracture in an implant
The Fragment Fork is marked with the thread size. The instrument is for manual use only and is used together with a Restorative Driver Handle.
The Fragment Drill is used for creating an indentation in the abutment screw/bridge screw fragment. The drills are marked with diameter
The Screw Extractor is used for the removal of abutment screw fragments. The Screw Extractor is marked with a diameter. The instrument is for manual use only and is used together with a Surgical Driver Handle.
Instruments to clean internal threads The Thread Cleaner is used for cleaning of internal threads in an implant/abutment. The Thread Cleaner is marked with the thread size. The instrument is for manual use only and is used together with a Restorative Driver Handle.
Abutment screw fractures may occur in implants when unfavorable stress or forces are applied. There are different options to remove an abutment screw fragment in an implant:
1500 rpm
Option
Repair Procedure Implant Level
1
Fragment Fork → Thread Cleaner
2
Fragment Drill → Fragment Fork → Thread Cleaner
3
Fragment Drill → Screw Extractor → Thread Cleaner
4
Remove implant with Implant Retriever or Trephine Drill
Guiding Cylinder EV 1. Attach the Guiding Cylinder EV to the Guiding Cylinder Handle.
2. Position the Guiding Cylinder EV in the implant and hold it firmly. NOTE: Ensure that the Guiding Cylinder EV is aligned with the vertical axis of the implant throughout the whole procedure. 3. Use the Guiding Cylinder EV to guide the Fragment Drill or Fragment Fork when removing abutment screw fragments in the implants.
Subject to change without prior notice. Other languages are available upon request.
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 5979-EN Rev. 001 A 2022-09
2 (5)
Instructions for Use Fragment Fork 1. Attach the Fragment Fork to the Restorative Driver Handle. 2. Position the Fragment Fork in the Guiding Cylinder EV. 3. Rotate the Fragment Fork manually counterclockwise while pressing towards the screw fragment. 4. When the screw fragment is loose, continue unscrewing the screw fragment. 5. Remove the Guiding Cylinder EV and remove the screw fragment with a pair of forceps or a similar instrument. NOTE: ● If the screw fragment cannot be removed with Option 1, go to Option 2 and use the Fragment Drill to make an indentation in the screw fragment for the Fragment Fork. ● If the screw fragment cannot be removed with Option 2, go to Option 3 and use the Fragment Drill to make a full depth indentation in the screw fragment for the Screw Extractor. Thread Cleaner 1. Attach the appropriate Thread Cleaner to the Restorative Driver Handle. 2. Insert the Thread Cleaner carefully into the implant. Make sure to engage it properly in the threads. 3. Work intermittently the entire length of the thread, about half of a turn at a time. Turn the Thread Cleaner back in between to clean the threads and remove possible fragments.
Fragment Drill 1. Attach the Fragment Drill to a contra-angle handpiece. 2. Position the Fragment Drill in the Guiding Cylinder EV. 3. Start drilling counterclockwise with the Fragment Drill through the Guiding Cylinder EV at a maximum speed of 1500 rpm under profuse irrigation with sterile physiological saline solution. NOTE: Ensure that the indentation is centered in the screw fragment. 4. Work intermittently with the Fragment Drill and reverse in between to clean out possible fragments. 5. Stop drilling when a small cavity/indentation is created in the screw fragment. NOTE: When using Option 3, drill gently until a full depth cavity is created in the screw fragment. The drill limit is reached when the upper end of the black marking is in line with the upper end of the Guiding Cylinder EV. Screw Extractor 1. Attach the Screw Extractor to the Surgical Driver Handle. NOTE: Make sure that the Screw Extractor is correctly placed into the handle. The hexagonal part of the shaft shall be fully inserted into the handle. 2. Position the Screw Extractor in the implant. 3. Turn the Screw Extractor manually counterclockwise into the screw fragment (without the Guiding Cylinder EV). 4. Use the Torque Wrench EV and turn counterclockwise to remove the screw fragment. Maintain downward pressure on the Screw Extractor.
Removal of an implant If all other methods to remove an abutment screw fragment are unsuccessful, use the Implant Retriever or the Trephine Drill to remove the implant. NOTE: ● Use the Implant Retriever for the removal of damaged implants or implants with damaged internal threads. ● Use the Trephine Drill for the removal of partly or fully osseointegrated implants. Implant Retriever 1. Position the Implant Retriever in the threaded area of the implant. 2. Turn counterclockwise while pressing the Implant Retriever down until the Implant Retriever sticks in position.
NOTE: In situations where only a short part of the screw hole remains, it may be difficult to achieve enough friction. In such cases, cut or grind off some of the instrument tip and try again.
3. Attach either an open-end wrench or the Restorative Driver Handle 4x4 low together with the Torque Wrench EV to the Implant Retriever. 4. Continue rotating counterclockwise while maintaining a downward pressure until the implant starts to rotate. 5. Continue until the implant is out of the bone. Trephine Drill If all other methods to remove a screw fracture/an implant are unsuccessful, a final option is to use a Trephine Drill. IMPORTANT: This procedure should be used at the lowest possible speed under profuse irrigation and with the bone exposed for optimal visibility. 1. Select the appropriate Trephine Drill. 2. Attach the Trephine Drill to a contra-angle handpiece. 3. Position the Trephine Drill over the implant. 4. Start drilling at the lowest possible speed (max. 300 rpm) under profuse irrigation with sterile physiological saline solution. Make sure to follow the axis of the implant. 5. Stop drilling when the top of the implant reaches the appropriate depth marking on the Trephine Drill. 6. Remove the implant with a pair of forceps.
Bridge screw fracture in an abutment Bridge screw fractures may occur in abutments when unfavorable stress or forces are applied. There are different options to remove a bridge screw fragment in an abutment: Option
Repair Procedure Abutment Level
1
Fragment Fork → Thread Cleaner
2
Fragment Drill → Fragment Fork → Thread Cleaner
3
Remove abutment with Rescue Driver Uni Abutment EV or Uni Abutment Retriever
NOTE: If the screw fragment cannot be removed, remove the implant.
Subject to change without prior notice. Other languages are available upon request.
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 5979-EN Rev. 001 A 2022-09
3 (5)
Instructions for Use Guiding Cylinder Uni Abutment EV 1. Attach the Guiding Cylinder Uni Abutment EV to the Guiding Cylinder Handle.
2. Place the Guiding Cylinder Uni Abutment EV onto the Uni Abutment EV and hold it firmly. NOTE: Ensure that the Guiding Cylinder Uni Abutment EV is aligned with the vertical axis of the abutment throughout the whole procedure. 3. Use the Guiding Cylinder Uni Abutment EV to guide the Fragment Drill or Fragment Fork when removing bridge screw fragments in the Uni Abutment EV. Fragment Fork 1. Attach the Fragment Fork to the Restorative Driver Handle. 2. Position the Fragment Fork in the Guiding Cylinder Uni Abutment EV. 3. Rotate the Fragment Fork manually counterclockwise while pressing towards the screw fragment through the Guiding Cylinder Uni Abutment EV. 4. When the screw fragment is loose, continue unscrewing the screw fragment. 5. Remove the Guiding Cylinder Uni Abutment EV and remove the screw fragment with a pair of forceps or similar instrument. NOTE: ● If the screw fragment cannot be removed with Option 1, go to Option 2 and use the Fragment Drill to make an indentation in the screw fragment for the Fragment Fork. ● If the screw fragment cannot be removed with Option 2, go to Option 3 and remove the abutment using the Rescue Driver Uni Abutment EV or the Uni Abutment Retriever. Thread Cleaner 1. Attach the appropriate Thread Cleaner to the Restorative Driver Handle. 2. Insert the Thread Cleaner carefully into the screw hole. Make sure to engage it properly in the threads. 3. Work intermittently the entire length of the thread, about half of a turn at a time. Turn the Thread Cleaner back in between to clean the threads and remove possible fragments.
Fragment Drill 1. Attach the Fragment Drill to a contraangle handpiece. 2. Position the Fragment Drill in the Guiding Cylinder Uni Abutment EV. 3. Start drilling counterclockwise with the Fragment Drill through the Guiding Cylinder Uni Abutment EV at a maximum speed of 1500 rpm under profuse irrigation with sterile physiological saline solution. NOTE: Ensure that the indentation is centered in the screw fragment. 4. Work intermittently with the Fragment Drill and reverse in between to clean out possible fragments. 5. Stop drilling when a small cavity/indentation is created in the screw fragment.
Removal of Uni Abutments If all other methods to remove a bridge screw fragment are unsuccessful, a final option is to use the Rescue Driver Uni Abutment EV or the Uni Abutment Retriever to remove the abutment. NOTE: ● Use the Rescue Driver Uni Abutment EV for the removal of Uni Abutments EV. ● Use the Uni Abutment Retriever to remove Uni Abutments with damaged internal threads or damaged Uni Abutments in TX implants or implants carrying the EV connection. Rescue Driver Uni Abutment EV 1. Attach the Rescue Driver Uni Abutment EV to the Surgical Driver Handle. NOTE: Make sure that the Rescue Driver Uni Abutment EV is correctly placed into the Surgical Driver Handle. The hexagonal part of the shaft shall be fully inserted into the handle. 2. Attach the Surgical Driver Handle to the Torque Wrench EV. 3. Position the Rescue Driver Uni Abutment EV in the abutment. The arrow on the head of the Torque Wrench EV indicates the direction in which the wrench is functioning and should be in ”out” (reverse) mode. 4. Use the Torque Wrench EV and turn counterclockwise to loosen the abutment. 5. Remove the abutment with a pair of forceps or another appropriate instrument. NOTE: The Rescue Driver Uni Abutment EV does not have any pick-up function. Uni Abutment Retriever 1. Position the Uni Abutment Retriever in the threaded hole of the abutment. 2. Turn counterclockwise while pressing down until the Uni Abutment Retriever friction fits in the threads.
NOTE: In situations where only a short part of the screw hole remains, it may be difficult to achieve enough friction. In such cases, cut or grind off some of the instrument tip and try again.
3. Attach either an open-end wrench or the Restorative Driver Handle 4x4 low together with the Torque Wrench EV to the Uni Abutment Retriever. 4. Continue rotating counterclockwise while maintaining a downward pressure until the abutment loosens. 5. Continue manually until the abutment is completely removed.
Follow-up After treatment is completed, good oral hygiene and regular follow-up examinations are important to maintain health.
Subject to change without prior notice. Other languages are available upon request.
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 5979-EN Rev. 001 A 2022-09
4 (5)
Instructions for Use Delivery – Storage – Disposal Delivery Product
State of Delivery
Single Use / Multiple Use
Expected Lifetime (number of uses/years)*
The mechanical processing method was validated with the following materials and devices (acc. to ISO 15883 and AAMI TIR 30): ● Washer disinfector, type G 7836 CD, Miele & Cie. KG, Gütersloh ● Cleaning program VARIO TD Pre-rinsing with cold water 4 min Cleaning 10 min from 45–55 °C Neutralization 6 min Intermediate rinsing with cold water 3 min Thermal disinfection 5 min at 90 °C (A0 ≥ 3000) Drying 30 min at 105 °C ● Cleaning agent neodisher® MediClean forte (0.5 %)/neutralization agent neodisher® Z (0.1 %), Dr. Weigert, Hamburg.
Guiding Cylinder EV
Non-sterile
Single use
1 use
Guiding Cylinder Uni Abutment EV
Non-sterile
Single use
1 use
Guiding Cylinder Handle
Non-sterile
Multiple use
150 uses
Fragment Fork
Non-sterile
Single use
1 use
Screw Extractor
Non-sterile
Single use
1 use
Thread Cleaner
Non-sterile
Single use
1 use
Maintenance
Fragment Drills
Non-sterile
Single use
1 use
Trephine Drills
Non-sterile
Single use
1 use
Implant Retriever
Non-sterile
Multiple use
-
Rescue Driver Uni Abutment EV
Non-sterile
Multiple use
150 uses
Uni Abutment Retriever
Non-sterile
Multiple use
-
Before sterilization, all products should be inspected with the naked eye for visible soil, impairments and/or corrosion. Particular attention should be paid to design features such as channels, blind holes, threads, undercuts and mating surfaces. Check all markings on products for visibility and readability by inspection with the naked eye. Check matching components for proper assembly and functionality. Check products with movable parts for correct operation. Check pre-mounted components for completeness and integrity. Dispose of defective products.
* Instruments must be replaced before the indicated number of uses/years is reached if they are damaged or dull.
For type and size see product label. NOTE: Do not use the products if the packaging is damaged.
Storage Store the products at room temperature in the original packaging under conditions normal for dental practices.
Disposal For disposal of the packaging and components comply with the currently applicable national waste disposal regulations in your country. Instruments and components that were used in the patient’s mouth may be potentially infectious and must be disposed of safely in containers approved for this purpose. Dispose of sharps immediately after use in designated puncture-proof containers according to ISO 23907-1 to prevent infection and injury.
Material Product
Material
Sterilization Sterilization is to be performed corresponding to the following scheme: 1. Preparation for sterilization: Place components in a sterilization pouch which is legally marketed (for the US market: FDA-cleared) for use with the recommended sterilization parameters. Packaging must comply with the requirements according to EN ISO 11607, ANSI/AAMI ST79 and AAMI TIR12. Every sterilization package must have a sterilization indicator and sterilization date. 2. Parameters (acc. to ISO 17665, EN 13060, EN 285 and AAMI TIR12) Method
Cycle
Temperature
Exposure Time*
Dry Time
Steam (EU**)
Dynamic air removal (prevacuum)
134 °C
3 min
20 min
Steam
Dynamic air removal (prevacuum)
132 °C (270 °F) 135 °C (275 °F)
4 min 3 min
20 min
Steam
Gravity displacement
121 °C (250 °F)
30 min
20 min
* Minimum exposure times, the operating times are longer and may vary depending on the device. ** EU customers are required to use these steam sterilization parameters.
3. Storage: Store the sterilized components dry and dust-free at room temperature.
Guiding Cylinder EV
Stainless Steel acc. to ASTM-F899
Guiding Cylinder Uni Abutment EV
Stainless Steel acc. to ASTM-F899
Guiding Cylinder Handle
Stainless Steel acc. to ASTM-F899
Fragment Fork
Tungsten-Carbide
Screw Extractor
Stainless Steel acc. to ASTM-F899
Thread Cleaner
Stainless Steel acc. to ASTM-F899
Inform us (Dentsply Sirona) and your competent authority in the case of notice of life-threatening incidents or a severe deterioration in health status related to one of our products.
Fragment Drills
Stainless Steel acc. to ASTM-F899, Tungsten-Carbide
Trademarks
Trephine Drills
Stainless Steel acc. to ASTM-F899
Implant Retriever
Stainless Steel acc. to ASTM-F899
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 trademarks and nothing herein shall be interpreted to the contrary.
Rescue Driver Uni Abutment EV
Stainless Steel acc. to ASTM-F899
Uni Abutment Retriever
Stainless Steel acc. to ASTM-F899
Additional Information for EU Customers
Cleaning and Sterilization IMPORTANT: Prior to clinical use, all components and instruments delivered non-sterile must be cleaned, disinfected and sterilized according to ISO 17664. Instruments that can be disassembled must be disassembled for cleaning and may be assembled again for sterilization only in a dry condition. Manual pre-cleaning Coarse soiling must be removed immediately (within a maximum of two hours) after use with a soft nylon brush until visibly clean. Ultrasonic cleaning The action times and concentrations specified by the manufacturer of the cleaning agent must be observed. Mechanical processing Manual pre-cleaning is necessary to ensure efficient mechanical cleaning. Suitable washer disinfectors as well as cleaning and neutralization agents are to be used for mechanical cleaning. The instructions from the manufacturer of the washer disinfector must be followed. Cleaning and neutralization agents are to be dosed and used in accordance with the manufacturer’s instructions. A cleaning program with thermal disinfection (A0 ≥ 3000) is recommended. Either demineralized water or water which satisfies this level of purity is recommended for cleaning.
Subject to change without prior notice. Other languages are available upon request.
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 5979-EN Rev. 001 A 2022-09
5 (5)