Non-sterile Surgical Instruments and Auxiliaries Instructions for Use

ucts may lead to infection or unplanned physical injury. ѹ Do not use damaged, corroded or blunt instruments. Always inspect instruments before use. ѹ Avoid the mandibular nerve canal during implant bed preparation and implant insertion. Nerve damage may result in anesthesia, paresthesia or dysesthesia. ѹ Do not exceed the recommended insertion torques as this might cause bone necrosis. Specific warnings Planning ѹ In cases where highly vulnerable anatomical structures are located closer than 3 mm to the planned implant, it is recommended to use additional measuring methods following measurement with the x-ray reference foil. ѹ To avoid scaling errors, the foil must not be copied. ѹ The x-ray reference sphere (art. no. 049.076V4, ∅ 5.0 mm) is depicted on the transparencies of the x-ray template / x-ray reference foil at the corresponding scale diameter size. ѹ Adhere to the production requirements of the holding template and ensure that the x-ray sphere is securely fixed within the holding template. Use the x-ray template specific to the implant and follow the procedures described in the procedure manuals and brochures listed in the Further information section of these instructions for use. Implant bed preparation and implant placement ѹ Due to the construction and function of the drills, the drill tip is a maximum of 0.5 mm longer than the implant insertion depth. This additional length must be taken into consideration in the planning phase. ѹ Ensure correct drilling depth by using the recommended surgical planning (including radiographic evaluation), depth marks on the drills, drill stops, depth gauges and alignment pins. Straumann® non-sterile surgical instruments have depth marks in 2 mm intervals that correspond to the available implant lengths. ѹ When measuring osteotomy depth, make sure that the depth gauge is inserted to the full depth of the osteotomy. Use drills and taps with clockwise rotation. Use drills in ascending order of diameter. Use intermittent drilling and provide ample cooling with pre-cooled (5 °C, 41 °F) sterile saline solution. ѹ Bone quality should be considered during implant bed preparation.

Do not exceed the following drill speeds: Surgical step Alveolar ridge preparation, non-guided

Cutting instrument

Speed [rpm]

Needle Drill ∅ 1.6 mm Round Bur ∅ 1.4/2.3/3.1 mm

800

Milling Cutter ∅ 2.2 mm Milling Cutter ∅ 2.8 mm

600

Milling Cutter ∅ 3.5 mm Alveolar ridge preparation, guided

Straumann iGuide™ Milling Cutter ∅ 3.5 mm

500

Milling Cutter ∅ 4.2 mm Milling Cutter, ∅ 5.0 mm

400

Straumann iGuide™ Milling Cutter ∅ 5.0 mm VeloDrill™, all diameters Straumann iGuide™ Drills, all diameters Drilling, guided and non-guided

Profile drilling, guided and non-guided Taps, guided and non-guided

800

All other drills ∅ 2.2 mm All other drills ∅ 2.8 mm

600

All other drills ∅ 3.5 mm

500

All other drills ∅ 4.2 mm

400

Profile drills, all diameters Straumann iGuide™ Profile Drill P1, P2 & P3 Taps, all diameters

300 15 or manual

Drill for Template Fixation Pin, ∅ 1.3 mm Template Fixation

Straumann iGuide™ Drill for Template Fixation Pin, ∅ 1.5 mm

800

ѹ Straumann iGuide™ drills are used with the cor-

responding T-sleeve inserted in the templates, without the need of drill handles. Guided drills must be used in combination with the corresponding drill handles and sleeves inserted in the templates. Inspect the drill handles for operational reliability before every surgery. Inspect the surgical template for correct fit, orientation, and stability before every surgery. Ensure proper fit of the drill handle inside the sleeve inserted in the surgical template. For ∅ 1.3 mm/1.5 mm template fixation pins, drill until the drill stop touches the sleeve, then manually insert the template fixation pin until the stop touches the sleeve. In flapless surgery, do not apply any force to the drill template fixation pins to avoid soft tissue damage. ѹ Guided profile drilling is not applicable for

WT (TLX), WT (TLC) and WN (TL S/SP) implant beds. Do not start drilling until the guide of the profile drill engages the slotted sleeve. Avoid loosening the sleeves by firmly fixing them to the surgical template during surgery. Avoid ap-

plying any radial or axial load on the sleeves to help ensure proper retention of the sleeves in the surgical template.

6. Caution/precautions ѹ It is essential to handle components according

to the basic information documentation on the surgical and prosthetic procedure. Ensure sterile handling. ѹ Never use potentially contaminated components. Only use adequately processed devices if indicated for multiple uses. ѹ Handling with care at all times is recommended to avoid needlestick injuries. ѹ Users must exercise caution when using an AS component with prosthetic components fabricated using a non-validated workflow. In such cases, a maximum angulation of 20 ° is recommended. Proper functionality of an AS component is not guaranteed at greater angulations. Specific caution/precautions Planning ѹ During surgical planning, ensure the correct use of planning instruments, accurate fabrication and proper use of drill guides and surgical templates. Implant bed preparation ѹ Inspect the instruments before use. Always adhere to the recommended drill speeds. To ensure correct drilling and alignment, use drill templates and drill stops, depth marks on drills, depth gauges and alignment pins and position indicators (only for SC and Straumann® PURE Ceramic Implant, monotype). The hard bone tap may only be used in class I hard bone. Regularly inspect the quality of instruments and use the surgery tracking sheet for Straumann® cutting instruments to ensure that these instruments are not overused. When using osteotomes, mount the depth stop and introduce the instruments into the bone without excessive force. ѹ For TorcFit™ Implant drivers, check that the patient’s open mouth offers sufficient space for the implant driver instrument length. Use tweezers to engage and disengage the profile drill with the Fine Implant Bed Adapter (FIBA).

7. Residual risks and side effects The clinical outcome of dental treatment is influenced by multiple variables. The following possible residual risks and side effects relate to this device and may lead to additional treatment at the dentist’s office: ѹ Bite/mastication/phonetic problems ѹ Bone damage ѹ Bone compression ѹ Discomfort ѹ Hypersensitivity/allergic reactions 3

ѹ Implant fracture ѹ Gingival injuries ѹ Longer recovery/healing time than expected ѹ Loss of implant

Laser marking on Implant type the Guided Adapter and Guided Implant Driver TLX/TLC SP

Straumann® Tissue Level Fully Tapered Standard Plus, Straumann® Tissue Level Apically Tapered Standard Plus

BLX/BLC

Straumann® Bone Level Fully Tapered, Straumann® Bone Level Apically Tapered

ѹ Loss of prosthetic components ѹ Other toxicity reactions ѹ Poor esthetic outcome ѹ Risk of surgical implant explantation ѹ Risk of swallowing/inhaling small parts during

the procedure

SCS

ѹ Recall to the dentist’s office

AS (Angled solution) Screwdrivers

ѹ Additional treatment at dentist’s office

the pre-treated products with ultrasonic support for at least 10 minutes at room temperature (20 °C ± 2 °C). Always follow the manufacturer’s instructions. ѹ Finally, rinse out all cavities of the products three times (3x) under running deionized water at room temperature (20 °C ± 2 °C) for at least 10 seconds, or until no dirt residues are visible. ѹ After the cleaning process make sure devices are dry before packaging them for sterilization. If additional drying is necessary, dry in a clean location.

ѹ Sinus perforation ѹ Damage to adjacent/opposing teeth ѹ Nerve damage possibly resulting in chronic pain

Screws

ѹ Paresthesia ѹ Dysesthesia ѹ Vertigo ѹ Swelling ѹ Local inflammation ѹ Bruising ѹ Maxillary/mandibular ridge bone resorption ѹ Systemic or local infection (including peri-im-

plantitis, periodontitis, gingivitis, fistula) ѹ Minor bleeding ѹ Local pain

NC

RC NNC RN/ RB/ NT/ NC/ NNC RN/ RB/ NT/ WN WB RT/ RC WN WB RT/ WT WT

All AS components are identified by green color coding. Please note that SCS and AS components are not compatible with each other.

10. Cleaning and disinfection 8. Note Do not re-use multiple-use devices more than the number of times indicated on the label. Check the product label carefully and use accordingly.

9. Compatibility information Straumann® non-sterile surgical instruments are available in a variety of configurations. Make sure only to use Straumann® non-sterile surgical instruments with other parts of the Straumann® Dental Implant System with the corresponding connection and size. Please be aware that the following guided adapters and guided implant drivers must be used for the corresponding implant types: Laser marking on Implant type the Guided Adapter and Guided Implant Driver

For single-use devices follow the following procedures: The Straumann® devices are delivered non-sterile and must be cleaned and sterilized prior to intra-oral use. Automated cleaning is preferred, if available. Prior to processing, remove the packaging system from the product. Straumann recommends the following procedure for pre-treatment: ѹ Place the articles in a water bath for at least 10 minutes. ѹ Pre-clean by rinsing under running water while brushing the outer and inner surfaces with suitable brushes. ѹ All movable components should be actuated three times (3x) under running water. Rinse out all cavities of the articles five times (5x) with water using a disposable syringe (minimum syringe volume 20 ml).

SP/NNC/TE

Straumann® Standard Plus Implant, Straumann® Narrow Neck CrossFit® Implant, Straumann® Tapered Effect Implant

S

Straumann® Standard Implant

BL/BLT

Straumann® Bone Level Implant, Straumann® Bone Level Tapered Implant Not compatible with Straumann® Bone Level Tapered ∅ 2.9 mm Small CrossFit® connection

The pre-treated products can be cleaned either manually with ultrasonic support or by using an automated cleaning method (recommended).

TLX/TLC S

Straumann® Tissue Level Fully Tapered Standard, Straumann® Tissue Level Apically Tapered Standard

Straumann recommends the following procedure for manual cleaning: ѹ When using a manual cleaning method, choose an appropriate cleaning detergent (e.g. CIDEZYME®, 0.8%, Johnson & Johnson) and clean

Straumann recommends the following procedure for automated cleaning in a Washer-Disinfector: ѹ When using an automated cleaning method place the pre-treated product in the washer-disinfector so that joints are opened, and water can flow out of cannulas and blind holes. ѹ Choose an appropriate program suitable for instrument and an appropriate cleaning detergent (e.g. neodisher® MediZym, 0.5%, Dr. Weigert). Follow the manufacturer’s instructions. ѹ Remove the devices from the washer-disinfector after the end of the program. ѹ After the cleaning process make sure devices are dry before packaging them for sterilization. If additional drying is necessary, dry in a clean location. For sterilization, follow the procedure defined in the “Sterilization” section. Processing validation study information Detergent for manual cleaning:

0.8 % CIDEZYME®, (Johnson & Johnson)

Detergent for automated cleaning:

0.5 % neodisher® MediZym, (Dr. Weigert)

Washer-Disinfector:

Miele Professional G 7836 CD

Instrument rack:

Rack E 439/3 or E327 (Miele)

For multiple-use devices follow the following procedures: The Straumann® devices are delivered non-sterile must be cleaned, disinfected, and sterilized prior to intra-oral use. Automated cleaning and thermal disinfection are preferred, if available. Prior to processing, remove the packaging system from the product. Straumann recommends the following procedure for pre-treatment: ѹ Place the articles in a water bath for at least 10 minutes. ѹ Pre-clean by rinsing under running water while brushing the outer and inner surfaces with suitable brushes. ѹ All movable components should be actuated three times (3x) under running water. Rinse out all cavities of the articles five times (5x) with 4

water using a disposable syringe (minimum syringe volume 20 ml). The pre-treated products can be cleaned and disinfected either manually with ultrasonic support or by using an automated method (recommended). Straumann recommends the following procedure for manual cleaning: ѹ When using a manual cleaning method, choose an appropriate cleaning detergent (e.g. CIDEZYME®, 0.8%, Johnson & Johnson) and clean the pre-treated products with ultrasonic support for at least 10 minutes at room temperature (20 °C ± 2 °C). Always follow the manufacturer’s instructions. ѹ Finally, rinse out all cavities of the products three times (3x) under running deionized water at room temperature (20 °C ± 2 °C) for at least 10 seconds, or until no dirt residues are visible. ѹ After the cleaning process make sure devices are dry before disinfection. If additional drying is necessary, dry in a clean location.

ѹ Choose an appropriate program suitable for in-

strument and an appropriate cleaning detergent (e.g. neodisher® MediZym, 0.5%, Dr. Weigert). Follow the manufacturer’s instructions. ѹ Perform thermal disinfection at 90°C for 5min ѹ Remove the devices from the washer-disinfector after the end of the program. ѹ After the cleaning process make sure devices are dry before packaging them for sterilization. If additional drying is necessary, dry in a clean location.

Straumann recommends the following procedure for automated cleaning and thermal disinfection in a Washer-Disinfector: ѹ When using an automated cleaning method place the pre-treated product in the washer-disinfector so that joints are opened, and water can flow out of cannulas and blind holes.

12. Procedure

For sterilization, follow the procedure defined in the “Sterilization” section.

Consult the basic information brochures mentioned in the “Further information” section for a detailed step-by-step description. Straumann® non-sterile surgical instruments are devices for transient use in the oral cavity and intended for continuous use for less than 60 minutes.

Processing validation study information

13. Further information

Detergent for manual cleaning:

0.8 % CIDEZYME®, (Johnson & Johnson)

Detergent for automated cleaning:

0.5 % neodisher® MediZym, (Dr. Weigert)

Detergent for manual disinfection:

CIDEX® OPA, (ASP™)

Washer-Disinfector:

Miele Professional G 7836 CD

Instrument rack:

Rack E 439/3 or E327 (Miele)

Further information regarding different types of Straumann® non-sterile surgical instruments and other components of the Straumann® Dental Implant System is available online on the Straumann website or via the local Straumann organizations: ѹ Straumann® Product Catalog (452.200/en) ѹ Straumann® Dental Implant System, Basic Infor­ mation (702084/en) ѹ Straumann® Guided Surgery, Basic Information (702083/en) ѹ Straumann® Surgical and Prosthetic Instruments, Care and Maintenance (702000/en) ѹ Straumann® Bone Level Tapered Implant, Basic Information (702167/en) ѹ Straumann® Drill Stop – Precise depth control (152.053/en) ѹ Straumann® PURE Ceramic Implant System, Basic Information (702406/en) ѹ Straumann® VeloDrill™ System for Guided Sur­ gery, Basic Information (702526/en) ѹ Straumann® BLX Implant System, Basic Informa­ tion (702115/en) ѹ Straumann® Mini Implant System, Basic Informa­ tion (702403/en) ѹ Straumann® Drill Stop, Basic Information (702874/en) ѹ Straumann® TLX Implant System, Basic Informa­ tion (702854/en) ѹ Straumann® BLC Implant System, Basic Informa­ tion (705651/en) ѹ Straumann® TLC Implant System, Basic Informa­ tion (705650/en) ѹ Straumann iGuide™, Basic Information (707930/ en)

11. Sterilization Straumann recommends the following procedure for manual disinfection: ѹ After cleaning, place the devices in the bath of disinfection solution, e.g. CIDEX® OPA, for 12 minutes at room temperature (20 °C ± 2 °C). Ensure that the devices are covered by the disinfection solution. ѹ Rinse out all cavities of the devices three times (3×) with disinfection solution at the beginning and at the end of the action time using a disposable syringe (minimum syringe volume: 20 ml). ѹ Remove the devices from the disinfection bath and immerse the articles completely in a large volume of fresh purified water. Rinse the devices thoroughly, especially all cavities, with purified water five times (5×) using a disposable syringe (minimum syringe volume: 20 ml). ѹ Repeat the previous rinse steps, for a total of three (3x) rinses. Always use large volumes of fresh purified water for each rinse. Do not reuse the water for rinsing or any other purpose. Residues may cause serious side effects. ѹ Dry the devices inside and out with filtered compressed air. Make sure devices are dry before packaging them for sterilization. If additional drying is necessary, dry in a clean location.

Note: For users outside the United States, if visible signs of moisture are present (damp spots on sterile packaging, pooled water in the load) at the end of the sterilization cycle, repackage and re-sterilize using a longer drying time.

Individually double pouch the devices in sterilization pouches prior to sterilization. Sterilize according to the following parameters: Method

Conditions

Drying time

For Europe: Moist Heat (Autoclave) 134 °C (273 °F) Fractionated vacuum for 3 min

Local practice

For the United States and Canada: Moist Heat (Autoclave) 132 °C (270 °F) Fractionated vacuum for 4 min

30 min

For countries outside Europe, the United States and Canada Moist Heat (Autoclave) 132 °C (270 °F) to Local practice Fractionated vacuum 134 °C (273 °F) for at least 3 min

Note: For users in the United States, use devices immediately after sterilization. Do not store sterilized devices. Note: For users outside the United States and Canada, sterilized devices should be used immediately after sterilization. In case of storage, validate the effectiveness of the storage according to your internal process. Follow the manufacturer’s instructions for the sterilization accessories and storage containers.

14. Storage Note: Users in the United States should ensure that the sterilizer and all sterilization accessories (sterilization wraps, pouches, sterilization trays, biological indicators and chemical indicators) are cleared by FDA for the intended sterilization cycle.

The devices must be stored in a dry place in their original packaging at room temperature and protected from direct sunlight. Improper storage may compromise essential material and design characteristics, leading to device failure.

5

15. Disposal Disposal should be handled in an environmentally sustainable manner according to local regulations. Hazardous waste from contaminated devices or sharps should be disposed of in appropriate containers which meet specific technical requirements.

Straumann® and/or other trademarks and logos from Straumann mentioned herein are the trademarks or registered trademarks of Straumann Holding AG and/or its affiliates.

19. Availability Some items of the Straumann® Dental Implant System are not available in all countries.

16. Information to be provided to the patient

Symbols

Information on contraindications, warnings, precautions, side effects and complications with Straumann devices should be provided to the patient.

The following table describes the symbols that may be printed on the packaging label. Please refer to the packaging label for the applicable symbols related to the product.

17. Please note

Symbol

Symbol Source

Consult instructions for use ISO 15223-1 Follow the link to the eIFU: ifu.straumann.com

The Straumann Product must be used in accordance with the instructions for use provided by the manufacturer. It is the practitioner’s responsibility to use the device in accordance with these instructions for use and to determine whether the device fits the patient’s individual situation.

CE marking is the manufacturer's declaration that the product meets the requirements of the MDR (EU) applicable EC legislation. 2017/745 Where applicable: The identification number of the Notified Body shall follow this symbol.

The Straumann Product is part of an overall concept and must only be used in conjunction with corresponding original components and instruments distributed by Institut Straumann AG, its ultimate parent company and all affiliates or subsidiaries of the parent company (“Straumann”). Use of third-party products not distributed by Straumann voids any warranty or other obligation, express or implied, of Straumann.

Authorized representative in the European Community

ISO 15223-1

Indicates the entity importing the medical device into the European Union

Institut Straumann AG

Catalogue number

ISO 15223-1

Batch code

ISO 15223-1

Serial number

ISO 15223-1

Medical device

Institut Straumann AG

Do not re-use

ISO 15223-1

Do not use more than 10 times

Institut Straumann AG

Do not use more than 20 times

Institut Straumann AG

Non-sterile

ISO 15223-1

The Straumann® Lifetime Guarantee and Straumann® Guarantee Questionnaire are available in hardcopy and online on the website of the appropriate local Straumann organization.

Symbol Description

Symbol Source

Sterilized using aseptic processing techniques and ethylene oxide

Institut Straumann AG

Single sterile barrier system

ISO 7000

Single sterile barrier system with protective packaging inside

ISO 7000

Double sterile barrier system

ISO 7000

Do not resterilize

ISO 15223-1

Do not use if package is damaged

ISO 15223-1

Keep away from sunlight ISO 15223-1 Symbol Description

Practitioners must have knowledge of dental implantology and instruction in the handling of the Straumann product described herein (“Straumann Product”) to use the Straumann Product safely and properly in accordance with these instructions for use.

Any issues that arise in relation to the device should be reported together with the impacted product to the local Straumann organization. In the event of a serious incident, the user must file a report to the local Straumann organization and the appropriate competent authority as required by local regulations. Straumann also offers an e-Product Complaints Service in designated countries.

Symbol

SN

U.S. federal law restricts this device to sale by or 21 CFR 801.109(b) on the order of a dental (1) professional.

Manufacturer

ISO 15223-1

Qty.:

Quantity

Institut Straumann AG

Date of manufacture

ISO 15223-1

Pat.:

Patent Marking Follow the link to the patent information: pat.straumann.com

Institut Straumann AG

Use-by date

ISO 15223-1

e.g.:

Temperature limit (e.g.: min 5 °C / max. 20 °C)

ISO 15223-1

e.g.:

Upper limit of temperature (e.g.: max. 20 °C)

ISO 15223-1

e.g.:

Lower limit of temperature (e.g.: min. 5 °C)

ISO 15223-1

Keep dry

ISO 15223-1

Caution

ISO 15223-1

Contains hazardous substances

ISO 7000

Sterilized using irradiation

ISO 15223-1

18. Validity

Sterilized using ethylene ISO 15223-1 oxide

Upon publication of these instructions for use, all previous versions are superseded.

Sterilized using aseptic processing techniques

Contains biological ISO 7000 material of animal origin custommade device

Custom-made device

MDR (EU) 2017/745

ISO 15223-1

© Institut Straumann AG, 2024. All rights reserved. 6