Standard straight 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 range of superstructure options, including cemented, screwed, customised and removable prostheses, CAD-CAM solutions and scan bodies, as well as auxiliary prosthetic parts and temporary parts.

• Bases (abutments): placed on dental implants to support prosthetic reconstructions such as crowns or bridges. See the catalogue for superstructures compatible with the platform diameter and length of the abutments.
• Screws: the screw is used to fix the superstructure to the dental implant.
• Healing heads: used in single-stage, transmucosal surgical protocols and screwed into the dental implant, protecting its internal structure; they do not support a prosthetic superstructure.
• General information: most superstructures are suitable for use throughout the patient’s lifetime. Temporary abutments can be shortened to the implant screw level depending on the patient’s oral anatomy.

Each superstructure package has a lot number on it, and there are three lot number labels inside each pack. For retrospective traceability, it is strongly recommended that these labels are kept in the patient’s file together with the panoramic X-ray.

Intended use: cemented abutments are intended for use with NucleOSS Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures for edentulous or partially edentulous patients.

Indications: NucleOSS T6 and T6 Torq superstructures are prefabricated prosthetic components directly connected to endoosseous 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.

Standard straight abutment: used in cemented restorations and compatible with all diameters of T6 and T6 Torq implants. It has a platform switching feature that ensures soft tissue-abutment compatibility and has an internal hex connection feature.

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

• 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.

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:

• When polishing the abutments, ensure that the part entering the implant is protected, or perform this process with the abutment attached to the implant analogue.
• 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 with the torque values given in Table 1.
• 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 superstructures are tightened more or less than the specified torque values, it may cause the abutments and/or implants to fail.
• The appropriate torquing values for the use of superstructures can be found in Table 1.

Before surgery:

• 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 (e.g. 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, superstructures 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 superstructure and the time of application should be evaluated.
• NucleOSS superstructures are medical devices that do not require installation. It is strongly recommended that specialists who will use them for the first time receive training from NucleOSS. For more information, contact NucleOSS dealers or representatives, or email 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. They fall into two groups.

• 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/).

Cemented abutments of the NucleOSS Dental Implant System are made from Grade-23 titanium alloy according to the ISO 5832-3 standard. They are offered for sale as non-sterile and must be sterilised before use by the end user. The cleaning section also refers to titanium alloy (Gr 23), PEEK and chrome-cobalt materials.

For the standard straight abutment, in the procedure the M.1.6 standard connection screw is tightened by hand with a hex key and then torqued to a maximum of 30 Ncm with a NucleOSS ratchet.

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.

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

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

• 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.
• Note: the sterilisation parameters and methods shown are validated by NucleOSS Dental Implants. According to EN ISO 17665, the ultimate responsibility for the validation of sterilisation techniques and equipment is directly associated with the processor. All autoclaves/sterilisers must be maintained and validated in accordance with EN ISO.
• Please refer to the implant user manual for implant sterilisation information.

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.

The standard straight abutment is compatible with all diameters of T6 and T6 Torq implants. The impression caps are colour-coded by prosthetic platform diameter, as in the table below.

Reference: the connection screw T6 16007, used to attach the abutment to the plaster model in the laboratory.

4. To fix the abutment to the implant, a yellow connection screw is used; the screw is inserted with a hex key and tightened by hand.

6. The assembled analogue group is pressed from behind and the flat surface of the rest is placed on the flat surface of the impression part in the tray so that it fits into the impression cap in the tray.
7. A plaster model is created with the help of an impression tray.

6. The dental prosthesis is placed so that the flat surface inside it coincides with the antirotation surface of the abutment and sent to the clinic together with the plaster model to be fitted to the patient.

1. The healing cap or temporary abutment is removed from the patient’s mouth.
2. If there is blood, tissue or pus inside the implant, it is cleaned with vacuum.
3. Before placing the created single tooth prosthesis in the patient’s mouth, the sterilised standard flat abutment is carefully placed on the implant in the patient’s mouth.
4. To fix the abutment to the implant, the M.1.6 standard connection screw is tightened by hand (manually) with a hex key.
5. The connection screw should be torqued to a maximum of 30 Ncm with a NucleOSS ratchet.

6. Excess cement is carefully removed from the patient’s mouth to prevent gingival recession.

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

Summary of safety and clinical performance: with the launch of the European Medical Devices Database, a summary for NucleOSS T6 and T6 Torq bodies will be available at https://ec.europa.eu/tools/eudamed.

Serious adverse events: for the patient, user or third party in countries with Regulation 2017/745/EU on Medical Devices, if a serious adverse event occurs during or as a result of 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 contact for reporting. Basic UDI-DI: 869938335SSA2Z (Standard Straight Abutment).

Symbols and their meanings:

• 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 this symbol.