Astra Tech Implant System EV Reusable Products EV Instructions for Use

Instructions for Use Small Tray EV Bone Reamers

Adverse Reactions

The Tray provides guidance in the selection of Bone Reamers per implant size. ● Straight line – first option ● Dotted line – alternative option

Adverse reactions during or after implant 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 ▪ Temporary anesthesia or paresthesia and masticatory impediment ▪ Pain ● Implant loss ● Peri-implantitis ● Local or systemic infection ● Bone loss as a result of peri-implantitis or mechanical overload ● Fracture or damage of implants, healing components, prosthetic components or prosthesis ● Removal and replacement of an implant ● Esthetic or functional complications

Intended Use Implant Driver EV / Implant Driver Profile EV The Implant Drivers EV are used for picking up the implant from the blister, carrying it to the implant site and installing the implant. Hex Drivers EV The Hex Drivers EV are intended for tightening and releasing screws with an internal hexagonal screw head.

MRI Safety Information

Implant Depth Gauge EV The Implant Depth Gauge EV is intended for measuring the depth of the osteotomy.

Step-by-Step Instructions

Abutment Depth Gauge EV The Abutment Depth Gauge EV is intended for measuring the mucosal height over the implant in millimeters. Small/Large Trays EV The Trays are intended for organizing, sterilizing and storing of instruments. Small Tray EV Bone Reamers The Small Tray EV Bone Reamers is intended for organizing, sterilizing and storing the Bone Reamers EV.

Indications Partial and total edentulism

Contraindications Allergic or hypersensitivity reactions to materials used (see section “Material”)

Warnings Surgery in the oral cavity and oral rehabilitation include general risks for complications: ● 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.

Not applicable for the Reusable Products EV.

Implant Driver EV NOTE: ● The Implant Driver EV can be used for a maximum of 500 implant installations. ● Do not exceed 45 Ncm when installing the implant. If not completely seated before reaching 45 Ncm, reverse/remove the implant and widen the osteotomy appropriately. It is recommended to have a titanium forceps available in case the implant driver does not provide sufficient carrying function during the removal procedure. 1. Attach the appropriate Implant Driver EV to a contra-angle handpiece or a surgical driver handle. NOTE: To avoid damage to the Implant Driver EV use a contra-angle handpiece or a surgical driver handle provided with a hexagon that engages the hexagon on the shaft of the Implant Driver EV. 2. Carefully rotate the Implant Driver EV in the implant to align the indexing tabs. 3. Before picking up the implant, make sure the Implant Driver EV is fully seated into the implant.

Precautions ● ● ● ● ● ● ●

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. 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. Products intended for manual use shall not be used together with a contraangle handpiece. Improper patient selection/analysis or failure to comply with the instructions for use can lead to failed osseointegration or loss of osseointegration. Inadequate cooling, incorrect implant site preparation, incorrect instrument settings or excessive installation torque can result in failed implant.

4. Press downwards to activate the carrying function.

5. Install the implant manually or with a contraangle handpiece at low speed (25 rpm) under profuse irrigation with sterile physiological saline solution. 6. Position the implant at the marginal bone level or slightly below. 7. Position one of the dimples on the Implant Driver EV buccally to facilitate an optimal placement of the abutments. 8. Release the Implant Driver EV by lifting it gently from 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 5977-EN Rev. 004 D 2022-09

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Instructions for Use Implant Driver Profile EV NOTE: ● The Implant Driver Profile EV can be used for a maximum of 500 implant installations. ● Do not exceed 45 Ncm when installing the implant. If not completely seated before reaching 45 Ncm, reverse/remove the implant and widen the osteotomy appropriately. It is recommended to have a titanium forceps available in case the implant driver does not provide sufficient carrying function during the removal procedure. 1. Attach the appropriate Implant Driver Profile EV to a contra-angle handpiece or a surgical driver handle. 2. Align the dimple/flat surface on the Implant Driver Profile EV with the most apical point of the implant slope. NOTE: To avoid damage to the Implant Driver Profile EV use a contra-angle handpiece or a surgical driver handle provided with a hexagon that engages the hexagon on the shaft of the Implant Driver Profile EV. 3. Before picking up the implant, make sure the Implant Driver Profile EV is fully seated into the implant. NOTE: The Implant Driver Profile EV seats in only one position in the implant. 4. Press downwards to activate the carrying function.

5. Install the implant manually or with a contraangle handpiece at low speed (25 rpm) under profuse irrigation with sterile physiological saline solution.

3. Sterilize the tray with instruments in a sterilization pouch according to the sterilization instructions (see section “Cleaning and Sterilization”). 4. Perform the surgery. 5. After surgery, clean and sterilize the tray and instruments.

Delivery – Storage – Disposal Delivery Product

State of Delivery

Single Use / Multiple Use

Expected Lifetime (number of uses/years)*

Implant Driver EV / Implant Driver Profile EV

Non-sterile

Multiple use

500 uses

Implant Depth Gauge EV

Non-sterile

Multiple use

1500 uses

Abutment Depth Gauge EV

Non-sterile

Multiple use

1500 uses

Hex Driver EV

Non-sterile

Multiple use

1500 uses

Small Tray EV

Non-sterile

Multiple use

3000 uses

Large Tray EV

Non-sterile

Multiple use

2000 uses

Small Tray EV Bone Reamers

Non-sterile

Multiple use

3000 uses

* 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 blister 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

Implant Driver EV / Implant Driver Profile Stainless Steel acc. to ASTM-F899 EV Implant Depth Gauge EV

6. Position the implant buccally at the marginal bone level or slightly below. 7. Align the dimple/flat surface on the implant driver with the most apical point of the slope to facilitate optimal placement of the implant. 8. Release the Implant Driver Profile EV by lifting it gently from the implant.

Hex Driver EV Manual/Machine 1. Attach the Hex Driver EV to a contra-angle handpiece or a surgical/restorative driver handle. The Hex Driver Manual has an integrated handle. 2. Use the Hex Drivers EV for fixation of screws, pins and components that carry an internal hexagon.

Implant Depth Gauge EV Insert the Implant Depth Gauge EV into the osteotomy and measure the depth by using the laser markings corresponding to implant lengths.

Abutment Depth Gauge EV

Titanium Alloy (Ti6Al4V-ELI) acc. to ASTM-F136

Abutment Depth Gauge EV

Titanium Alloy (Ti6Al4V-ELI) acc. to ASTM-F136

Hex Driver EV

Stainless Steel acc. to ASTM-F899

Small Tray EV

PPSU plastic (Polyphenylsulfone), Silicone

Large Tray EV

PPSU plastic (Polyphenylsulfone), Silicone

Small Tray EV Bone Reamers

PPSU plastic (Polyphenylsulfone), Silicone

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. ● Drills must be kept separated from each other when using ultrasonic cleaning, e.g. keep the drills hanging in a holder during the ultrasonic cleaning. ● Trays equipped with instruments must not be cleaned in the washer disinfector. Trays and instruments must be cleaned separately. ● Trays must be cleaned disassembled. The trays should be reassembled and equipped with instruments before sterilization.

Mechanical Procedure

Insert the Abutment Depth Gauge EV into the implant and measure the mucosal height over the implant to select the appropriate abutment.

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.

Trays

Ultrasonic cleaning The action times and concentrations specified by the manufacturer of the cleaning agent must be observed.

1. Make sure the tray and instruments are cleaned prior to use according to the cleaning instructions (see section “Cleaning and Sterilization”). NOTE: The tray and the instruments must be cleaned separately. 2. Assemble the tray and load with instruments.

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 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 5977-EN Rev. 004 D 2022-09

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Instructions for Use 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. 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.

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 trademarks and nothing herein shall be interpreted to the contrary.

Maintenance 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.

Sterilization of single components 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 Steam (EU**) Steam Steam

Cycle Dynamic air removal (prevacuum) Dynamic air removal (prevacuum) Gravity displacement

Temperature 134 °C

Exposure Time* 3 min

Dry Time 20 min

132 °C (270 °F) 135 °C (275 °F) 121 °C (250 °F)

4 min 3 min 30 min

20 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.

Sterilization of an equipped tray NOTE: Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization is to be performed corresponding to the following scheme: 1. Preparation for sterilization: Place equipped tray 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 pouch 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)

4 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. Before storage of the tray, make sure that no signs of moisture are present. Otherwise repeat the sterilization process using a longer drying time. 4. Storage: Store the sterilized components dry and dust-free at room temperature.

Additional Information for EU Customers 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.

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 5977-EN Rev. 004 D 2022-09

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