T6 and T6 Torq temporary abutments

The NucleOSS Dental Implant System is an in-bone dental implant system with dental implants and related abutments, healing caps and surgical instruments. It is compatible with T6 and T6 Torq Superstructures, T6 and T6 Torq Dental Implants and the T6 Surgical Set. Failure situations that may occur as a result of use with different systems may harm the patient. The product label gives the product code, specification and production date.

The system offers a wide range of abutment options for different purposes with all bodies: cemented, screwed, customised, removable prosthesis, CAD-CAM solutions and scan bodies, as well as auxiliary prosthetic parts and temporary parts.

Abutments are placed on dental implants to provide support for prosthetic reconstructions such as crowns or bridges. See the catalogue for abutments compatible with the platform diameter and length. The screw is used to fix the abutment to the dental implant.

• Most abutments are suitable for use throughout the patient’s lifetime. However, NucleOSS Temporary PEEK Abutments should be kept in the patient’s mouth for less than 30 days and Temporary Titanium Abutments for more than 30 days.
• Temporary abutments can be shortened to the implant screw level depending on the patient’s oral anatomy.

Intended use: NucleOSS abutment and prosthesis parts are used to support crowns, bridges or superstructures in the lower and/or upper jaw, used with the NucleOSS Dental Implant in completely edentulous or partially edentulous patients.

Indications: NucleOSS T6 and T6 TORQ abutments are prefabricated prosthetic components directly connected to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation.

Target patient population: people with adult jaw structure where none of the contraindications for dental implantation apply. Target users: dentists licensed in dentistry.

Use of temporary abutments: they are used for the production of short-term temporary single tooth, bridge or total dentures held with cement. PEEK options are for short-term use and titanium options for long-term use, and they can be shaped easily. They can be used immediately after the surgical procedure, after the implant has healed and the cover is removed, or immediately after impression taking.

Expected clinical benefit: patients can expect to have one or more missing teeth replaced and/or crowns restored to restore chewing function.

All superstructures of the NucleOSS Dental Implant System are manufactured from Grade-23 titanium alloy according to the ISO 5832-3 standard. For PEEK, the standard cited is ASTM F2026-16 (Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications).

The products are offered for sale as non-sterile and must be sterilised before use by the end user.

• High blood pressure, cardiovascular disease, diabetes, bone metabolism disorders, uncontrolled bleeding disorders, inadequate wound healing capacity, inadequate oral hygiene, serious internal medical problems, incomplete development of the upper and lower jaw, poor general health, uncooperative and unmotivated patients, drug, alcohol or smoking addiction, psychoses, functional disorders resistant to long-term treatment, xerostomia (dry mouth), granulocytopenia (lack of white blood cells), Ehlers Danlos syndrome, radiation therapy, osteoradionecrosis, weakened immune system, renal failure, organ transplantation, fibrous dysplasia, crohn’s disease, steroid, corticosteroid or anticonvulsant use, prophylactic antibiotics, creatinine, serum calcium, titanium allergy, uncontrolled endocrine disorders, anticoagulation drugs, haemorrhagic diathesis, bruxism, parafunctional habits, unfavourable anatomical bone conditions, uncontrolled periodontitis, temporo-mandibular joint disorders, treatable pathological diseases of the mandible or changes in the oral mucosa, pregnancy, breastfeeding, osteoporotic fracture, respiratory disease, thyroid or parathyroid diseases.
• Patients with active osteolytic, inflammation, diagnosed malignancy, nodular growths, tenderness, unexplained swelling of the head or neck, infectious conditions at the implant site.
• Unrealistic patient expectations.
• Unattainable prosthetic reconstructions.
• Inadequate training of the practitioner.

Observance of precautions and warnings ensures safe handling and application.

• Use of the NucleOSS brand and sale of NucleOSS Dental Abutment System products are restricted to NucleOSS and its business partners.

• All models in the NucleOSS Dental Abutment system (T6, T6 TORQ) should be applied according to NucleOSS Surgical and Prosthetic protocols.
• It should be kept out of the reach of children.
• The abutment suitable for the patient’s oral structure should be used with the appropriate dental implant.
• The patient should be informed before and after the surgical operation.
• Abutments with damaged packaging should not be used.
• Make sure that the patient’s health condition is suitable for the operation.
• Abutments are sold as non-sterile. Before use, they must be sterilised by the user as specified in the instructions for use.
• Previously used abutments cannot be reused.
• The appropriate torque values for the use of abutments are given under Tightening torques below.

If the following warnings and precautions are not observed, complications may occur, such as the part entering the windpipe or swallowing the part.

During placement of the product, the dentist and auxiliary personnel must use appropriate personal protective equipment (PPE) to prevent the risk of interpersonal infection. The procedure should not be performed without gloves and masks.

For dental technicians:

• The abutment should be placed on the model by checking the correct orientation and making sure that it is fully seated.
• The abutment should be fixed with the abutment screw provided and tightened only by hand (PEEK products max. 10 Ncm, titanium products max. 30 Ncm).
• After this stage, the prosthesis suitable for the treatment should be created and removed from the model with the help of the correct hex key.

For dentists:

• The clinician should take the abutments from the laboratory and remove the temporary restorations, closure screws or healing caps from the patient’s mouth.
• After cleaning, disinfecting and sterilising the prosthetic parts from the laboratory, the clinician should apply them to the patient’s mouth by tightening them with a tightening piece according to the specified torques.
• If the abutments are tightened more or less than the specified torque values, it may cause the abutments and/or implants to fail.

Before surgery: a clinical and radiological examination of the patient should be performed preoperatively to determine whether the patient is suitable for treatment and to determine his/her psychological and physical condition.

Special attention should be paid to patients with localised or systemic factors that may interfere with the bone or soft tissue healing process or the osseointegration process (for example smoking, poor oral hygiene, uncontrolled diabetes, facial radiotherapy, infections in the lateral tooth or bone, bisphosphonate therapy).

The device has not been evaluated in paediatric/adolescent patients and is not recommended for use in children.

Surgery: all components, devices and instruments used during the procedure must be kept in good condition, and care must be taken to ensure that the instrumentation does not damage implants, abutments or other components.

Following implant placement, the surgeon’s assessment of bone quality and primary stability determines when the implants can be loaded. The choice of abutment and the time of application should be evaluated.

NucleOSS abutments are medical devices that do not require installation. It is strongly recommended that specialists who will use NucleOSS abutments for the first time receive training from NucleOSS.

If users need more information about the product, NucleOSS dealers and representatives can be contacted, or NucleOSS can be contacted by email at info@nucleoss.com.

After surgery: to ensure a long-term treatment outcome, regular comprehensive patient follow-up after implant treatment is recommended, together with the necessary information on proper oral hygiene.

The clinical outcome of dental treatment can be influenced by many variables. Possible residual risks and side effects may occur during or after the operation.

• Pain, swelling, phonetic difficulties, gingivitis.
• Dental implants, permanent paresthesia, dysesthesia, marginal bone loss, localised or systemic infections, oroantral or oronasal fistula, disruption of adjacent teeth, irreversible damage to adjacent teeth, implant fractures in the jaw, bone or prosthesis, nerve damage, exfoliation, chronic pain associated with hyperplasia, implant failure, fractures in the neck area where the implant and abutment meet, screw loosening or fracture, abutment fracture, abutment compression into the implant.

• The patient should be informed about contraindications, warnings, precautions, side effects and complications of NucleOSS dental implant systems.
• There is no residue, leakage or harmful residue on the surface of the device that could harm the user or the patient.
• The patient should be informed about the MRI compatibility of the NucleOSS products used.
• The surgical site should be kept clean before and after the operation, and the patient should be well informed about its cleanliness.
• The area where the implant and superstructure are placed should not be exposed to load with chewing movement in the early period.
• For detailed information, refer to the Patient Information Booklet (https://www.nucleoss.com/hastaya-ozel/).

References: the two hex wrenches named in step 1 of the procedure, the carrying-tightening hex wrench (T0 2025) and the hex wrench (T0 25253). See the catalogue for compatible abutments.

1. The healing cap attached to the implant is loosened with the carrying-tightening hex wrench (T0 2025) and taken off the implant with the help of the hex wrench (T0 25253).
2. It should be ensured that there is no bone or soft tissue on the implant platform.
3. The temporary abutment is placed on the implant and fixed to the implant with the connecting screw provided with the product. The screw must be tightened by hand.
4. Temporary abutments are marked to be shaped, taking into account the occlusal level of the bridge prosthesis to be created.

8. Once the shaping process is completed, the temporary abutment is placed back on the implant.
9. Before attaching the abutment, the bone and gum on the implant platform are cleaned; the internal connection area of the implant is washed and dried.
10. The sterilised abutment is placed on the implant and it is ensured that the implant-abutment connection is made properly.
11. The temporary titanium abutment is tightened with the M1.6 connection screw as it cannot be disassembled again.
12. Tightening should be done with a hex wrench or a torque wrench. The tightening torque value should be set as 30 Ncm for temporary titanium abutments and 10 Ncm for temporary PEEK abutments.

Note: applying torque higher than the recommended torque may result in failure of the abutment and/or implant. Less than the recommended torque may result in loosening of the abutment, which may result in abutment and/or implant failure.

5. After the acrylic dries, the bridge shell is removed and excess acrylic is cleaned and the temporary bridge is given its final shape. After the shaping process is completed, polishing is applied.

3. After the painting process, the prepared acrylic total dental prosthesis is carefully placed on the abutments. Holes are drilled in the painted marked areas of the lower part of the acrylic total dental prosthesis.

4. Acrylic total dental prosthesis is placed on the abutments, and the parts of the abutments remaining on the teeth are painted again to ensure correct shaping.

5. After painting, the acrylic thread is removed and the M1.6 connecting screws are removed. Temporary titanium abutments with painted tops are sent to the shaping process in turn.

8. After the temporary abutment and the acrylic total dental prosthesis are thoroughly fused together, the rubber materials in the abutment are removed, the M1.6 connection screws are removed, the prosthesis is removed and the excess acrylic on it is cleaned.
9. After going through procedures such as cleaning and polishing, the total dental prosthesis is finally placed on the implants. M1.6 connection screws are tightened by hand with a manual hex wrench, enough to hold on to the implants.
10. Finally, the screw holes are covered with a cotton-like material, and the process is completed by filling.

Note: before pouring acrylic, the screw hole of the abutments is covered with cotton or a cotton-like rubber material to prevent liquid from leaking into it.

This procedure should be considered a minimum guideline, with details in the NucleOSS Surgical Manual (https://www.nucleoss.com/kaynaklar/download/).

Tightening torques for abutment-related parts. Tightening more or less than the specified torque may cause the abutments and/or implants to fail.

Step 12 of the procedure sets 30 Ncm for temporary titanium abutments and 10 Ncm for temporary PEEK abutments.

NucleOSS T6 and T6 Torq superstructures are not sterile when delivered. The product must be cleaned, disinfected and sterilised before the superstructures are placed in the patient’s mouth. Details of the sterilisation process are given below.

• The superstructures are washed inside and outside with a soft bristle brush under running water.
• The superstructures are disinfected with a suitable disinfectant that will not damage the titanium alloy (Gr 23) and PEEK material.

All superstructures of the NucleOSS Dental Implant System are offered for sale as non-sterile. They must be sterilised before use by the end user. Before sterilisation, place the superstructures separately in sterilisation bags.

• After sterilisation, the products must be used immediately.
• A minimum valid sterilisation time and temperature is required to achieve a sterility assurance level of 10⁻⁶.
• The sterilisation parameters and methods shown are validated by NucleOSS Dental Implants. According to ISO 17665, the ultimate responsibility for validation of sterilisation techniques and equipment is directly associated with the processor. All autoclaves/sterilisers must be maintained and validated in accordance with ISO 17665.
• For implant sterilisation, see the implant instructions for use.

Non-clinical testing has shown that the NucleOSS Dental Implant System is “Conditional MR”. The patient can be safely scanned with this device immediately after placement under the following conditions:

• 1.5-Tesla and 3-Tesla magnetic static field.
• 4,000-gauss/cm (40 T/m) dimensional gradient magnetic field.
• Maximum reported MR system average specific absorption rate (SAR) for the body 2-W/kg.

Improper storage may jeopardise the basic material and design characteristics and may cause the device to malfunction.

Disposal of the device must comply with local regulations and environmental requirements, taking into account different levels of contamination. Hazardous waste from contaminated devices or sharps must be disposed of in appropriate containers that meet specific technical requirements.

A summary of safety and clinical performance for NucleOSS T6 and T6 Torq bodies will be available on the European Medical Devices Database (EUDAMED) at https://ec.europa.eu/tools/eudamed, with the launch of that database.

For patients, users and third parties in countries with Regulation 2017/745/EU on Medical Devices: if a serious adverse event occurs during or as a result of the use of this device, notify the manufacturer and your national competent authority. Manufacturer contact for reporting: NucleOSS, e-mail info@nucleoss.com. See the full instructions (PDF) for the web address.

Basic UDI-DI: 869938335TA7W (Temporary Abutment).

See the full instructions (PDF) for the symbol graphics.

• Product catalogue number
• Authorised representative
• Product lot number
• Read the operating instructions
• 2nd time not used
• Expiry date
• Do not use if the packaging is damaged
• Manufacturer
• Not sterile
• Prescription use only
• Medical device
• Distributor
• Producer country
• Warnings
• Unique device identifier
• Model number
• MRI safety information
• Importer
• CE marking: the manufacturer’s declaration that the product meets the requirements of the applicable EC legislation; where applicable, the identification number of the Notified Body will follow the symbol