General
Adin Dental Implant Systems Ltd. designs and manufactures advanced solutions for dental implantology.
Adin’s dental implant systems include implants, abutments and restorative components for dentists and dental technicians, and all required instruments and accessories for the fabrication of implant supported prostheses.
This User Manual relates to all Adin’s dental implant types: Swell™, Touareg™-S, Touareg™-OS, CloseFit™, Triple™ and One™.
This manual and the general Instructions for Use (IFUs) should be carefully read prior to use of Adin’s implant systems.

Intended Use
Adin dental implants are intended for surgical placement in the maxillary or the mandibular arches of edentulous or partially edentulous patients, to support single or multiple unit fixed restorations, or removable prostheses. Adin dental implants may be loaded when completely osseointegrated, or immediately, when adequate primary stability and occlusal stability are achieved.

Contraindications
Dental implants should not be placed in patients who are considered medically unfit for general or oral surgical procedures.
Special attention, and a thorough evaluation of potential risks and benefits should be given to patients who exhibit underlying medical factors that might affect bone or soft tissue healing processes (e.g., bone or connective tissue disorders, steroid treatments, radiation therapy, cigarette smoking).
Special accommodation should be practiced in patients with relative contraindications.
The placement of dental implants is not recommended in children and under-aged patients, until growth has stopped and epiphyseal closure is completed.
Local infections or pathologies, inadequate bone volume and/or quality as well as general diseases and treatments affecting bone and soft tissue healing may result in osseointegration failure, both immediately after surgery or at a later stage.
Note: Current best practices, clinical manuals, textbooks and publications should always be consulted for up-to-date information related to medical evaluation,treatment and planning the surgical procedures of patients undergoing implant placement procedures.

Preoperative Considerations and Precautions
Prior to any surgical procedure, patients must be carefully examined and evaluated to determine their medical, psychological and physical status.
Attention should be given to factors that may put the patient at risk or factors that may affect bone or soft tissue healing.
Panoramic radiographs, as well as CT scans and other individual radiographs must be obtained to enable a complete evaluation of the dental and periodontal status, as well as for the evaluation of available bone for future implant placement.
A comprehensive dental treatment plan, including the locations, number and sizes of planned implants should be formulated based on a comprehensive clinical and radiographic evaluation.
Constant communication and collaboration between the dental surgeon, the restorative dentist and the dental laboratory technician are critical to ensure optimal outcomes.
Whenever applicable, a wax-up and a surgical guide should be used, to ensure correct positioning of dental implants.
Sufficient residual bone volume is necessary in order to achieve high primary and long-term success of dental implants. In cases of inadequate bone volume, bone augmentation procedures should be considered.
The number of implants and their diameters, lengths and positions in a specific case must take into account the planned prosthetic type and each individual’s specific conditions and habits, such as bruxism or unfavorable jaw relations. Incorrect planning and implant placement may result in compromised esthetic results, undesirable restorative outcome, and increase risk of implant overload or mechanical failure.

Intraoperative Considerations and Precautions
The surgical placement of dental implants requires a high degree of precision and care.
Surgical procedures must always be performed using sterile instruments and tools.
All efforts must be made to minimize damage to both the soft and bone tissues during the surgical phase. Trauma, thermal injury and infection may result in implant failure or damage to the surrounding tissue.
Any divergence from the established surgical protocols increases the risk of osseointegration failure.
Loading and healing timing protocols should be determined based on bone quality and the implant’s initial stability.

Prosthetics Considerations and Precautions
Adin implant systems support all established dental implant restorative options.
Successful restorative and esthetic outcomes require proper planning related to the number and position of the implants. Treatment planning should also take into account mechanical stress and occlusal force distribution, to prevent excessive transverse loads (particularly in immediate loading cases).
Passive fit of the prosthesis over implants and abutments is mandatory.
The use of abutments or other components not manufactured by Adin may damage Adin’s implants. This, in turn, may lead to undesired prosthetic and/or esthetic results, and even to implant failure and damage to bone and soft tissues.

Implant Packaging
Adin implants are delivered in an outer cardboard box and internal double vial package.
A label on the outer package includes the following information: implant type, diameter and length, lot number, catalog reference number, manufacture date and expiration date. Two peel-off labels with identical information are included inside each implant package for easy and simple documentation in patients’ charts.
The outer implant vial cap is color coded for easy identification of the implant platform size.
Never use implants if package is damaged or contaminated in any way.

Product Sterility and Maintenance
Adin implants are provided sterile (by gamma radiation), and are intended for single use only.
Never reuse a dental implant and never use implants after their expiration date (indicated on the outer package label) or if package is damaged or contaminated. Such use may result in implant failure and damage to surrounding tissues.
Adin abutments are supplied non-sterile and must be sterilized prior to use.
Adin surgical and prosthetic kits are supplied non-sterile.
Kits and abutments must be sterilized using steam sterilization for 4 min at 132°C/270° F.

Hazards
To prevent aspiration or swallowing, attach a long dental floss to small instruments and pay special care while using them in patients’ mouths.
The Use of improper techniques during implant placement or during the restorative phase can result in implant failure and a substantial loss of surrounding bone.
Dental implants should never be reused.
Cover screws, healing abutments, temporary abutments and abutments should also not be reused, due to potential cross contamination. Reuse of these components may also result in product failure, as functionality cannot be guaranteed.
Incorrect treatment planning, and the use of wrong implant sizes, insufficient amount of implants and/or improper implant positioning may lead to mechanical failures of implants, components or restoration.
The use of narrow implants (NP and UNP implants) in the posterior region is contraindicated.

Warnings
Adin dental implants have not been evaluated for safety, compatibility, heating or migration in MR environment.
The label “Rx Only” refers to the following caution text: “Federal (USA) law restricts the sale of this device to, or on the order of, a licensed physician or dentist”.

Training and Education
Adin strongly recommends that dental professionals, both beginners and experienced implantologists, always keep up-to-date and current with published data and knowledge related to surgical and prosthetic treatment using dental implants and abutments.
Adin offers a wide range of courses at various levels, and provides support through a global network of experienced experts.
Please contact your local Adin representative for more information regarding certified training centers.

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