DentPross
DentPross Abutments , Components and Instruments Instructions for Use
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único responsable de velar por el uso de productos originales DentPross® y usarlos conforme a las instrucciones de uso y protocolos de manipulación correspondientes durante todo el proceso del tratamiento implantológico. El uso de componentes, instrumental o cualquier otro producto no original DentPross® que se use solo o en combinación con cualquiera de los productos originales DentPross® hará perder automáticamente cualquier garantía sobre los productos originales DentPross®. Consulte las condiciones de garantía con su distribuidor autorizado. Advertencia No todos los productos DentPross® están disponibles en todos los países. Consulte su disponibilidad. La marca DentPross® es una marca registrada, al igual que algunos de los productos mencionados o no mencionados en este documento. El fabricante se reserva el derecho a modificar, cambiar, eliminar o evolucionar cualquiera de los productos, precios o especificaciones técnicas referenciados en este documento o en cualquiera de sus catálogos sin previo aviso. Quedan reservados todos los derechos. Queda prohibida la reproducción o publicación total o parcial de esta documentación, en cualquier medio o formato, sin la correspondiente autorización por escrito del Fabricante. 12. Resonancia magnética No se ha evaluado la seguridad y compatibilidad de los productos DentPross® en un entorno de resonancia magnética ni se han sometido a prueba para ver si se calientan o migran en dicho entorno. 13. Función de medición El instrumental con función de medición presenta una precisión milimétrica. Al utilizar las fresas quirúrgicas hay que tener en cuenta la longitud de la punta de la fresa (+ 0,5 mm), ya que NO ESTÁ INCLUIDA en las mediciones de las diferentes marcas láser.
DentPross® prosthetic components and components Preparable straight abutments – Preparable angled abutments – Transepithelial abutments – Abutments for overdenture – Interphase abutments – Provisional abutments – Clinical screws – Cover screws – Healing abutments – Abutments with machined base – Impression abutments – Laboratory test abutments – Impression screws – Laboratory screws – Analogues – Scanbody – UCLA. 3. Indications for use It is essential to previously evaluate the patient by means of a clinical and imaging diagnosis and study of models, as well as to determine the possible contraindications for the treatment, prior to carrying out a treatment with DentPross® products. A correct treatment with dental implants must be based on a diagnosis, a treatment plan and a design of the prosthetic rehabilitation which meets the needs and expectations of the patient. Instruments The DentPross® surgical and prosthetic instruments are designed as one of the fundamental parts of the implant treatment. With the instruments, you will be able to carry out all the necessary processes for the preparation of the bone tissue, the insertion of the DentPross® dental implants and the manipulation of the different DentPross® prosthetic components or components. The surgical drills and trephine drills are designed to withstand a maximum of 45 uses under optimum conditions, whilst the circular scalpels are designed to withstand a maximum of 25. Improper use, lack of cleaning and maintenance or inadequate disinfection can reduce its number of uses. The DentPross® instruments are re-usable. Abutments The DentPross® prosthetic components or components are fixed to the DentPross® dental implants and serve as a support for the prosthetic rehabilitation. The prosthetic rehabilitation may be single or multiple, partial or total, and may be screwed or cemented to the abutments, or may be removable by means of implant anchorages or retainers.
Abutments, components and instruments
The attachments or abutments in biocompatible plastic material (PEEK) are for provisional use and are designed to be used in the mouth for a period of time no longer than 180 days. The removable prostheses with anchorages or retainers must be monitored at least once per year by the clinical professional. The correct intraoral adjustment of the prosthesis and the retention between the anchorages or retainers and the dental prosthesis must be verified. A loss of adjustment and/or a poor retention of the prosthesis put the prosthetic rehabilitation and the dental implants in danger.
INSTRUCTIONS FOR USE
The DentPross® abutments are single-use products.
IMPORTANT INFORMATION
4. Contraindications It is necessary to carry out a preoperative medical examination of the patient and to determine if absolute and/or relative contraindications or risk factors for the treatment with dental implants exist. The user is responsible for evaluating the potential risks and benefits of the implant treatment and for taking the pertinent decisions depending on the case. The DentPross® products must not be used on patients who lack the minimum medical conditions for receiving a prosthetic treatment and rehabilitation with dental implants.
EN | INSTRUCTIONS FOR USE
Read these instructions for use carefully before using the product. This document contains basic information for the use of the prosthetic instruments and abutments or components of the DentPross® original dental implant systems, from now on referred to as “DentPross® products”. This document has been written as a quick consultation guide for the practitioner responsible for the treatment, from now on referred to as “User”, and does not provide sufficient technical specifications for the correct use of the DentPross® products. It is not an alternative or substitute for specialised training and professional clinical experience. The DentPross® products must be used carrying out sufficient planning of the treatment and rigorously following the surgical and/or prosthetic protocols set by Biostar Laboratorios SLU. Read the specific surgical and prosthetic protocols for each product carefully, as well as the instructions for use and maintenance, before using any DentPross® product. You can read them on our website, www.biostar-lab.com, or request them from your official authorised Biostar Laboratorios SLU distributor. 1. Description of the system The DentPross® products are composed of dental implants, prosthetic components or components and surgical and prosthetic instruments. Biostar Laboratorios SLU has created a wide range of dental implant systems for the carrying out of dentistry treatments in accordance with the existing scientific bibliography and current clinical standards. Biostar Laboratorios SLU develops, manufactures and commercialises latest-generation implant products and a wide range of restorative solutions to respond to the particular needs of each patient. 2. Description of the products Instruments The DentPross® instruments are manufactured in stainless steel, grade 5 titanium and/or plastic. Some instruments are laser-engraved to facilitate identification and use. DentPross® instruments Surgical drills – Surgical taps – Insertion keys – Circular scalpels – Extenders – Surgical Trephine Drills – abutment adaptors – Screwdrivers – Drill stops – Bone expanders – Osteotomes – Ratchet wrenches – Screwdriver tips – Thread adaptors – Retreatment positioners – Paralleling pins – Depth measurers – Abutment extraction screws – Radiographic templates. Abutments The DentPross® prosthetic components or components are manufactured in grade 5 titanium, Cr-Co alloy and biocompatible plastic materials. Some DentPross® components, abutments and screws have an anodised colour depending on the type of prosthetic platform to facilitate identification and use (see catalogue).
Relative contraindications Age of the patient- Uncontrolled systemic disease- Poor oral hygiene- Active local infection - Pregnancy - Therapy with bisphosphonates - Sjogren syndrome - Uncontrolled endocrine disease- Radiation to head and neck- Allergy to stainless steel.- Stress- Psychological factors - Valve prostheses- Uncontrolled periodontal disease- Smoking- Alcoholism- Drug addiction - Addictions in general. Absolute contraindications The manufacturer does NOT recommend the implant treatment in the following cases: Cardiovascular diseases or disorders – Haemophilia – Cirrhosis of the liver – Terminal pathologies – Epilepsy – Neoplasms under care with chemotherapy – Blood dyscrasias – Cancer – Uncontrolled diabetes – Untreated periodontitis – Infectious diseases – Leukaemia – Alterations of the immune system – Treatment with immunosuppressives – Allergy to titanium – Active treatments with radiotherapy – Indefinite treatments with corticosteroids – Treatments with anti-coagulants – Involuntary muscle disorders – Serious liver disorders – Endocrine disorders – Psychiatric and/or psychological disorders. Biostar Laboratorios SLU will update these contraindications when necessary, based on the information obtained through clinical studies and post-sales information. 5. Storage The DentPross® products must be stored in their original packaging, in a clean, dry place, protected from sunlight and adverse conditions. 6. Packaging and supply state The DentPross® instruments and prosthetic components or components are supplied packaged in a thermosealed plastic bag; the product inside is identified with a label stuck to the back. Biostar Laboratorios SLU recommends that the traceability of the abutments used be maintained by recording the reference and the lot used in in the patient’s file. Biostar Laboratorios SLU guarantees that all its products follow an exhaustive process of manufacture, control and cleaning before being packaged. The correct integrity of the packaging must be controlled before using the DentPross® products, checking that it is not damaged. If there is any defect or damage, it must not be used and must be notified to Biostar Laboratorios SLU or to the official authorised distributor.
7. Cleaning and sterilisation The instruments and prosthetic components or components of the DentPross® dental implants systems are supplied NON-sterile. The instruments and the prosthetic components or components which are to come into contact with the mouth must be cleaned, disinfected and sterilised before use by following the cleaning, disinfection and sterilisation protocol for the Biostar Laboratorios SLU instruments, surgical boxes and abutments. You can consult it on our website www.biostar-lab.com or in the Biostar Laboratorios SLU catalogues. [For USA, the recommend validated sterilization cycle using steam and gravity autoclave is: 132°C / 270°F, minimum 15 minutes and 15-30 minutes Dry Time]. 8. Precautions Surgery and Instruments The surgical protocols describe in detail the precautions and important factors to take into account during the surgical process of fitting the dental implants. Prior to the intervention, it is essential to have consulted the surgical protocol of the product, as well as all the indications about its correct usage indicated in the catalogues of the DentPross® products. Particular attention must be paid and the necessary measures taken to prevent the instruments, of such small size, from being swallowed or breathed into an airway. All the DentPross® instruments for manual use incorporate retaining elements between each other or for use with dental floss, to avoid accidental ingestion. It is important to reduce the time of surgery and the damage done to the area receiving the implants, paying special attention to bone trauma and the asepsia of the surgical field. The correct preparation of the surgical site is a fundamental factor in the success of the treatment. This process requires that the surgical protocol for drilling set by the manufacturer for each type of implant and the correct use of the surgical drills, both in terms of the number of uses and of the working speeds, be followed rigorously. The surgical drills and taps must be used with constant abundant irrigation to prevent overheating of the bone. Take special care not to apply excessive forces or torques during the insertion of the implant. It is important to control the insertion torque of the implant, both in insertion with contraangle, and with insertion with ratchet wrench. Attention When a surgical instrument with a limited number of uses is used, that number must not be passed, as this would put the process of osseointegration, and therefore the treatment, in grave danger. The maximum torque for insertion of the dental implants is 50 Ncm. Exceeding the maximum insertion torque indicated for the implants can cause serious damage to the dental implant, to its connection, to the transporter and to the clinical screw included. Prosthetic rehabilitation The surgical protocols describe in detail the precautions and important factors to take into account during the surgical process of fitting the prosthetic rehabilitation. The design, the type of rehabilitation and the execution of the dental prosthesis must be studied prior to the insertion of the dental implants. Take special care not to apply excessive forces during the tests of the abutments or dental prostheses; this must always be done manually. Pay special attention to the definitive adjustment of the rehabilitation; the torque applied to the definitive clinical screws must be correctly controlled following the manufacturer’s indications, whether carried out mechanically or manually. DentPross® Torque table for abutments: Element/Abutment Cover screws/healing abutments Impression abutment screws Laboratory screws Clinical screws direct to implant O.Ring Abutments Simpro® Abutments Jocker® Abutments NetCam® Scanbody + screw TCam® Scanbody + tornillo Clinical screws on Joker®
Instrument/Tool Hex. screwdriver 1,25mm Hex. screwdriver 1,25mm Hex. screwdriver 1,25mm Hex. screwdriver 1,25mm NMXP10 / NLXP10 Insertion key NLOSD10 Insertion key NMA20 Insertion key Hex. screwdriver 1,25mm Hex. screwdriver 1,25mm Hex. screwdriver 1,25mm
Torque Manual Manual 10 Ncm 30 Ncm 30 Ncm 30 Ncm 30 Ncm Manual Manual 20 Ncm
Some instruments are designed for use with a contra-angle. In order to guarantee a correct connection of both products, please see the contra-angle manufacturer’s instructions for use. Attention Applying insufficient torque can cause incidents of loosening of said screws. If this occurs, we recommend replacing them with new products, as retightening a screw increases the risk of fatigue and fracture of it. Exceeding the maximum torque applied to the clinical screws indicated by the manufacturer can cause serious damage to the dental implant, to its connection, to the prosthetic abutment and to the clinical screw. Always check the passive adjustment of the implant-prosthesis unit. An incorrect passive adjustment puts the prosthetic rehabilitation in grave danger and can cause future damage to the dental implant, to its connection, to the prosthetic abutment, to the clinical screw and/or cause the loss or reabsorption of bone. 9. Warnings The planning of the treatment and the fitting of the DentPross® dental implants requires specific dentistry training. The specifications of the product alone do not
guarantee a proper use of it. The users are recommended to attend specialised theoretical/practical training courses to become familiar with the work techniques and protocols suitable for each product, including biomechanical, radiographical and prosthetic requirements associated with the implant treatment. Biostar Laboratorios SLU periodically holds diverse courses so that the users can update their knowledge of the work procedures and techniques of the DentPross® implants systems. It is the user’s obligation to inform themselves of and familiarise themselves with the current state of technique for each product and of its possible applications. Before using DentPross® products, it is necessary to know and be familiar with the corresponding surgical and prosthetic procedures. The patient must meet sufficient anatomical and psychological conditions to undergo the treatment with dental implants. The user must ensure the correct planning of the treatment, guaranteeing its safety with a minimum margin for error and respecting the vital oral structures and the general health of the patient. The procedure for use of the surgical drills, taps and other surgical instruments needed for the fitting of the implants is specified in the surgical protocols corresponding to each type of implant. The fitting of the implant and the prosthetic planning must adapt to the patient’s individual conditions, and in particular to a correct distribution of forces. The passive adjustment in the prosthetic rehabilitation structure and the adjustment of the occlusion must be achieved, and the appearance of excessive lateral forces avoided. A treatment with an insufficient number of implants, or an unsuitable choice of size and position to withstand and transmit the loads expected, can cause mechanical failure of the implant, of the abutment or prosthetic components or of the clinical screws due to overburdening or fatigue and substantial bone loss around the implant. A qualitatively or quantitatively insufficient alveolar bone, the appearance of infections or diseases in general, and changes in the habits of the patient, are some potential causes of failure of the osseointegration and of the treatment. The lack of bone tissue or soft tissue can give rise to a deficient aesthetic result. An unsuitable prosthetic rehabilitation can cause the failure of the whole rehabilitation treatment. The reuse of single-use products carries the danger of possible deterioration of their properties. The geometry of the product may have suffered damage during previous use or due to an unsuitable use. This implies the risk of surgical or prosthetic failure and/or harm to the patient’s health. Electrosurgery is not indicated due to the conductivity of the dental implants. 10. Adverse or side effects Many adverse or undesired effects can present themselves in current implantology. These are documented in the specialised scientific bibliography and published in journals and books specialised in the dentistry sector. However, the most relevant are: Post-operative discomfort – Localised pain – Localised inflammation – Haematomas – Haemorrhages – Localised or systemic infections – Difficulty speaking – Bone loss and/or fracture – Loss of the implant – Damage to adjacent teeth – Fractures to the implants and/or prosthetic components – Fracture of instruments – Injury to adjacent anatomical structures (inferior alveolar nerve or maxillary sinus). Biostar Laboratorios SLU will update these side effects when necessary, based on the information obtained through clinical studies and post-sales information. 11. Information on responsibility, safety and guarantee The indications for use and handling of the DentPross® products are based on the international published bibliography, the current clinical standards and our clinical experience with our products, and therefore should be understood as indicative general information. The handling and use of the DentPross® products, being out of the control of Biostar Laboratorios SLU, are sole responsibility of the user of them. Biostar Laboratorios SLU, its subsidiaries and/or official authorised distributors assume no responsibility, whether express or implicit, full or partial, for the possible harm or damages which may result from the improper handling of the product or from any other event not specified in its protocols and manuals for the correct use of its products. The user of the product must ensure that the DentPross® product used is suitable for the intended procedure and purpose. Neither these instructions for use, nor the work and product handling protocols, absolve the user of this responsibility. The use, handling and clinical application of the DentPross® products must be carried out by qualified professional staff, with the necessary qualifications in compliance with the legislation in force in each country. The use, handling and/or application of the DentPross® products, whether fully or in part, at any stage, by unqualified staff or staff without the necessary qualifications, automatically renders any kind of guarantee void and can cause serious harm to the health of the patient. The DentPross® products form part of their own system, with their own design characteristics and work procedures. This includes the dental implants, abutments or prosthesis components and the surgical or prosthetic instruments. The use of DentPross® products in combination with elements or components from other manufacturers can cause failure of the treatment, cause tissue damage, cause damage to the bone structures, inadequate aesthetic results and serious harm to the patient’s health. For this reason, only original DentPross® products must be used. The clinical professional responsible for the treatment is the sole person responsible for ensuring the use of original DentPross® products and for using them in conformity with the corresponding instructions for use and handling protocols for the whole duration of the implant treatment process. The use of components, instruments or
Simbología de códigos de etiquetado y catálogo norma ISO 15223-1 Symbols of labelling codes and used in catalogues, standard ISO 15223-1 Symbole für Codes auf den Etiketten und im Katalog, Norm ISO 15223-1 Symbolique de codes d’étiquetage et catalogue norme ISO 15223-1 Simbologia dei codici di etichettatura e catalogo secondo la norma ISO 15223-1 Símbolos dos códigos das etiquetas e catálogo norma ISO 15223-1
Fecha de fabricación Manufacturing date Herstellungsdatum Date de fabrication Data di produzione Data de fabricação
Rx Only
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X X X X
Referencia del producto Product reference Artikelnummer Référence du produit Riferimento del prodotto Referência do produto X X X X
Fecha de caducidad del producto Product expiration date Verfallsdatum Date de péremption du produit Data di scadenza del prodotto Data de validade do produto
Caution. Federal law (US) restricts this device to sale by or on the order of a dentist or physician.
Producto esterilizado usando radiación por rayos Beta Sterilized using irradiation (Beta) Sterilisiert durch Bestrahlung Produit stérilisé à l’usage de radiation par rayons Beta Prodotto sterilizzato mediante l’irradiazione di Raggi Beta Produto esterilizado usando radiação por raios Beta
X X X X
Certificación y organismo notificado Certification and notified body Zertifizierung und benannte Stelle Certification et organisme de notification Certificazione e organo informativo Certificação e entidade certificadora
Fabricante del producto Product manufacturer Hersteller des Produkts Fabricant du produit Fabbricante del prodotto Fabricante do produto
Distribuido por | Distributed by | Verteilt durch | Distribué par | Distribuito da | Distribuido por:
NetPlus Dental Abutments SLU C/Laguna del Marquesado, 19 28021 - Madrid – España Tfno.: +34 91 385 42 51
Fabricante | Manufacturer | Hersteller| Fabricant | Produttore | Fabricante:
Biostar Laboratorios SLU Cuidado, Consultar documentación adjunta (Consulte el protocolo Implanto&Protésico) Caution, Consult accompanying documents (Implant&Prosthesis protocol) Achtung, Begleitdokumente beachten (Konsultieren Sie das chirurgische und prothetische Protokoll) Attention, Consultez la documentation ci-jointe (Consultez le protocole pour les implants et les prothèses) Attenzione, Consultare la documentazione allegata (Consultare il protocollo Impianto&Protesico) Cuidado, Consultar documentação anexa (Consultar o protocolo Implanto-Protésico)
Código de lote del producto Batch code Chargennummer Code du lot du produit N. di lotto del prodotto Código de lote do produto
Limitación de temperatura Temperature limitation Temperaturbegrenzung Limite de température Limite di temperatura Limitação de temperatura
C/Laguna del Marquesado, 19 28021 - Madrid – España
Producto un solo uso Single-use product Nicht wiederverwenden X Produit XXà usage unique X Prodotto monouso Produto de utilização única
Consultar las instrucciones de uso Consult instruction for use Gebrauchsanweisung beachten Consultez les instructions d’utilisation Consultare le istruzioni per l’uso Consultar as instruções de utilização
Más información More Information Weitere informationen Pour plus d’informations Maggiori informazioni
No reesterilizar Do not resterilize Nicht resterilisieren Ne pas restériliser Non risterilizzare Não reesterilizar
No utilizar si el embalaje está dañado Do not use if package is damaged Bei beschädigter Verpackung nicht verwenden Ne pas utiliser si l’emballage est endommagé Non utilizzare se l’imballaggio è danneggiato Não utilizar se a embalagem estiver danificada
Mais informação
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