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USE INSTRUCTIONS

(α) ZivEco Dental Implants

 

where α= FLY LINE, BUTTERFLY LINE, ZITAN LINE, SMILE LINE, PEARL LINE, DIAMOND LINE, OPAL LINE, CRYSTAL LINE, YALOS LINE, CARE LINE, WORLD LINE, SUN LINE, MOON LINE, LIFE LINE, WELL LINE, FAIR LINE, KING LINE, PRINCE LINE, MARK LINE

INTENDED USE: The ZivEco implants are designed to be surgically implanted in the maxilla or in the mandible to replace the dental roots.

ATTENTION: The product was designed and built exclusively for the provided conditions; any other use is considered improper and therefore dangerous. The manufacturer can not be held liable for any damages resulting from improper, erroneous and unreasonable use. The product should be treated and used only by trained staff, surgeons and dentists.

It should be pointed out that our products are sold with instructions of use, it is good that the doctor knows that these are not sufficient to be able to perform an operation for the installation of the implants without adequate preparation: it is necessary that the doctor often takes an appropriate course or training period with a surgeon or dentist with appropriate experience. Improper techniques can result in a failure of implant and substantial bone absorption. The implants should not be used in sites or situations different from those specifically mentioned. This use can result in a failure of the implant with relative destruction of bone support. The dental implants are designed to be used only with special drills for bone, provided in kits. In order to manipulate the implant only sterile powderfree gloves must be used, non-metallic or titanium instruments have to be used to avoid damaging or contaminating the implant.

Note: The law allows use of these products only to qualified doctors or dentists.

ACTIONS: The dental implant may be used in the mandible or in the maxilla. Several dimensions are available for use in cavities created in the newly formed bone or post-extraction alveolous.

DESCRIPTION: The dental implant, made of TITANIUM GRADE 4, which after various researches has shown to be among the most biocompatible materials, include endosseous, two components, transmucosal implants. For the prothetization it is disposable a program of secondary and tertiary prefabricated components, it is good that the doctor evidence and remember the code of implant system installed to be able to purchase the appropriate secondary component when it is time to install it. The surface has been carefully configured and manufactured so as not to be changed. The implants can be not processed (smooth) or treated with sandblasting process.

INDICATIONS: The implant is designed for in situ edentual use of the mandible or the maxilla to support a complete denture, as a pillar or interim terminal for a fixed bridge or partial denture or to replace a single tooth element.

SURGICAL PROCEDURE:

First stage: Engraving and detachment of the flap in total thickness, taking care not to damage the tissues.

Second stage: Preparation of the implant site through the use of included drills, using in sequence drills of increasing diameter until to obtain the size of the desired implant site. At this stage, the dentist must be careful not to overheat the bone, working with the low rotational speed instruments (300 rpm approximately), always using burs and sharp cooling

solution throughly with sterile saline solution. Enforcement of the tapping hand for sites that need to implant screw host implants: neven during this operation the dentist overheat the bone.

Third stage: Inclusion of implant being careful not to overheat the bone, expecially if screw implants are used.

Fourth stage: Inserting of screw or of the cap screw to prevent that organic substances or tissues fill the internal part of implant. The screw should not be over-tightened to avoid breakage or deformation.

Fifth stage: Suture of the flaps. This must be airtight and should not create excessive tension. It should be noted that the surgical techniques and installation of the equipment can be learned only in stages or attending specialist practitioners.

WARNINGS: The surgical stage should be preceded by a careful assessment of the patient. (The analysis of local and systemic contra-indications concernes the ability of normal healing, proper oral hygiene, adequate amounts of bone. The implant cannot be used in patients with blood diseases such as discrepancies, decompensate diabetes, hyperthyroidism, bruxism, oral infections, malignancies, severe heart disease, AIDS, acute hepatitis, rheumatoid arthrites. The installations are contra-indicated in heavy smokers or patients in case of inadequate bone support which makes impossible to use an appropriate implant.

The implants in the short length (8 mm) are not suitable for replacing a single tooth and should not be used with connections for slot. They are not designed to withstand lateral loads. They should not be used if there is sufficient height and width of  alveolar to support the implant.

CAUTIONS: The panoramic radiograph should be used to determine if there is a properly adequate bone to the proposed site as well as to locate the position of anatomic critical structures such as the mandibular canal, the mentonier hole, sinuses jaw and adjacent teeth. Palpation and examination of the target site installations are also required to determine the anatomy of available bone. A detailed clinical evaluation is necessary. The proper motivation of the patient is essential for the success of procedures.

SIDE EFFECTS: The surgical procedure above can lead to complications, which aren’t an obstacle to an installation in itself; these may be temporary as pain, swelling, inflammation of the gingiva or long term such as deiescence, non integration, paresthesia, edema, hematoma, infection, nerve injury and general allergies.

PACKAGING: The implants are supplied in a sterile packaging. If the package is damaged or the implants are contaminated by any means, they must be discarded. The implants must not be used after the expiry date on the label.

WARRANTY AND LIMITATIONS: The success of all implants depends on surgical technique, which must be done meticulously. A careful selection of patients and a final prosthetic restoration adapted to individual patient necessities and to other anatomical part are essential. The selection of individual implants or more ones of appropriate shape and size to existing anatomy is crucial for future success. For these reasons, the manufacturer strongly recommend that all dentists should follow one or more courses or symposia on endosseous dental implants in order to know the appropriate implant system before to try to include them in clinical practice. Since the manufacturer can not and should not control the factors relating to the services provided by including the selection of the patient and the surgical riabilitative technique, the manufacturer assumes no responsibility regarding the replacement of the product for failures or other adverse reactions resulting from any of these mistakes or lack of information on use of implant by the operator or the patient. The implants are made of titanium grade 4 and are supplied uncoated or sandblasted.

Titanium, in the numerous animal and human studies conducted for several years by the researchers, is highly biocompatible.

Our implants are exceptionally resistant to injury and fractures.

It is not possible to ensure that fractures or injury of an implant cannot result from trauma or other overloads, such as a severe traumatic occlusion. For the following reasons, the manufacturer does not extend the guarantee beyond that one contained in this warranty, or outside the descriptions contained in each item. This warranty replaces all other warranties, express or implied, including merchantability and adaptability to different situations. The manufacturer guarantees the product only if it is used by persons authorized to practice. The manufacturer only replace defective products, and only when these ones have proved to be defective and are returned to the manufacturer for the inspection and the replacement. The manufacturer are not responsible for damages of any kind caused by accidental or otherwise, where any claim or potential claim is based on theories of negligence or fault.

The reuse of products marked as single use can cause contamination of the product, infection to the patient and/or  function of the device other than as provided.


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