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使用说明

Instructions For Use

Indications:

IDI Implant System is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function.

Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted application.

The device is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

Contraindications:

Implants should not be placed anytime when there are general contraindications associated with elective oral surgery or radiation therapy.

Absolute and relative contraindications include, but are not limited to: cardiac and vascular disease, bleeding disorders, psychological disorders, uncontrolled diabetes mellitus, mineral, bone, or connective tissue disorders, renal disease, hepatic disease, auto-immune disorders, chemotherapy, decreased immune function due to disease or medications, infectious disorders, and adverse conditions caused by medications, such as Fosamax®. Further relative contraindications include poor oral hygiene, dry mouth bruxism, malnutrition, alcoholism, heavy tobacco usage, and history of radiation therapy.

Furthermore, the patient needs an adequate volume of residual bone for the placement of implants of sufficient size and number to support the anticipated functional loads to which the patient will subject these implants.

Warning:

IDI Dental Implant Systems should be placed and restored only by practitioners who are licensed and trained to perform these procedures. Adequate preoperative studies should be performed to examine the anatomic structures and to assess the biomechanical, functional, and esthetic requirements of each case. Radiographs or other diagnostic reviews should be performed to determine position and topography of the maxillary sinus, nasal cavities, inferior alveolar nerve, mental foramen, natural tooth positions and other anatomical features that may affect implant placement or prognosis. Consultation between the surgeon, restorative dentist, and dental laboratory is essential for success. Risks of implant placement and restoration include, but are not limited to: infection, implant failure, loss of bone and soft tissue, unfavorable aesthetic result, anesthesia, dysesthesia and paresthesia in the oral and facial areas, sinus infection, dislodgement of implants and instruments in the surrounding structures, damage to adjacent teeth, non-restorable implants, fracture of implants or restorative components, and loosening of implants or restorative components.

IDI Dental Implant System has unique measuring characteristics to allow full seating of the implant to the desired depth. In some instances, drill length reference lines measure longer than the stated length of the implant. It is recommended that the implant surgeon be thoroughly familiar with the specific measurement system being utilized and provide a suitable safety margin adjacent to any teeth and vital structures. Failure to recognize the difference between the actual length of the drill and radiographic measurements can result in permanent injury to the nerves or other vital structures by drilling beyond the depth intended, potentially resulting in permanent numbness to the lower lip and chin or other injuries.

IDI Dental Implant System has specific design characteristics for mating implants, abutments, prosthetic components, and instrumentation. Combining instruments and components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory aesthetic results.

One-hundred percent success cannot be guaranteed. Lack of adequate quantity and/or

quality of remaining bone, infection, inadequate surgical technique, poor patient oral hygiene, and generalized disease are some potential causes for failure of osseointegration, both immediately after surgery or after osseointegration is initially achieved. Pre-operative hard tissue or soft tissue deficits may yield a compromised aesthetic result or unfavorable implant angulation. With reszpect to children, routine treatment is not recommended until completion of alveolar growth has been verified, especially in the maxillary interior area.

Procedural Precautions, Surgery:

All efforts must be made to minimize damage to the host tissue. In particular, special

attention must be paid to thermal and surgical trauma and to the elimination of contaminants and sources of infection. The surgical procedure requires a high degree of precision and care. Any divergence from the principle of least possible trauma at implant installation increases the risk of failure to establish osseointegration. All drilling procedures should be performed at maximum 1000-2000 RPM with copious irrigation. The use of sharp drills, sufficient irrigation, an in-and-out drilling motion, short cutting cycles, waiting for the bone to cool, and use of pilot drills in successively increasing sizes are essential. Special care should be taken to avoid over or under preparation of the osteotomy. Implants should be inserted in such a way that they are stable and lack any mobility. Excessive insertion torque (greater than 80 Ncm) may lead to damage to the implant (especially narrower diameter implants) or instruments and fracture of the bone site. All instruments used in surgery must be maintained in good condition and care must be taken that the instruments do not damage the implants or other components. Precautions must taken to avoid the swallowing or aspiration of components used in implant dentistry. After the implant installation, the surgeon’s evaluation of bone quality and initial stability will determine when implants may be loaded.

An appropriate follow-up protocol should be followed. AIDI Biomedical, LLC suggest that dentists should call for technical support or take our training courses before using our IDI Dental Implant System in order to ensure the best results.

Procedural Precautions, Prosthetics:

Especially important is proper stress distribution through passive adaptation and fitting of the bridge to the implant abutments, adjusting occlusion to the opposing jaw, and avoiding excessive transverse loading forces. Immediate loading and immediate temporization require additional precautions and are not suitable for all cases. Because of the small size of prosthetic components, care must be taken that they are not swallowed or aspirated by the patient.

Instructions For Abutments For Restoration Of IDI Dental Implants:

After adequate osseointegration the implants should be uncovered, if necessary, and the cover screw should be removed. The internal part of the implant should be irrigated, freed from debris, and dried. If necessary, a healing abutment should be placed and the tissue should be allowed to heal around the healing abutment. A final abutment that is compatible with the implant should be chosen.

If the abutment is modified at chair side, it is advisable to make an impression and make a preliminary model to identify any undercuts prior to making the final impression. A carbide or diamond bur can be used with copious irrigation to remove the undercuts.

IDI UCLA Plastic Engaging Abutment can be waxed-up and casted for single unit/custom abutment/screw and cement retained restorations. IDI UCLA Plastic Non-engaging abutment can be waxed-up and casted for multiple unit restorations.

The indexing feature of the abutment should match the internal indexing feature of the implant. Adequate seating can be verified with a vertical bitewing radiograph.

If the abutment is modified in a laboratory, proper orientation of the abutment into the implant should be identified by means of a transfer jig or any other transfer device. Final abutment seating should be performed using an insertion driver compatible with the selected implant system and a torque wrench applying 32 Ncm of torque on the abutment or fastening screw.

Abutments should not be over-prepared, and the retention of restoration and the strength of the abutment should be taken into consideration. It is recommended that less than 50% of the structure of customizable abutments and less than 30% of straight abutments be removed. Modifying the abutment at the junction with the implant is not recommended.

IDI Dental Implants provide a double finishing-margin design. Dentists can restore porcelain margins at the apical finishing line to improve esthetics in case of implant plateform exposure due to tissue recession.

A restoration should be fabricated and inserted, while making sure that the restoration is

stable and occlusal load is appropriate.

Immediate loading is one of the most high risk procedures that can be performed only when good primary stability has been achieved with appropriate occlusal loading. In other words, we suggest only using immediate non-functional loading of our IDI Dental Implant Systems in the cases that a primary initial stability of the implant must exceed 70 Ncm.

Follow Up Care:

Patients should be instructed in appropriate oral hygiene and care of the implants and restorations. Periodic follow up appointments should be made to confirm and maintain adequate function of the implants and the health of the surrounding tissues. Patients should be advised to use a WaterPik® or wet/rinse his/her mouth often to relieve a symptom of dry mouth which may cause the failure of implant integration or infection.

Sterility:

IDI Dental Implants are supplied sterile, and are for single use only prior to the labeled expiration date (if applicable). Do not use implants if the packaging has been damaged or previously opened. Abutments and instruments are supplied non-sterile and must be cleaned and sterilized prior to use.

Steam Sterilization procedure: Place the autoclave pouch containing item to be sterilized into the autoclave and follow the specific instructions provided by the manufacturer for pouched items. In general a pouch must be sterilized by heating for 30 minutes at 250 deg F (121 deg C). Alternatively, follow a validated sterilization procedure.

Method of Supply:

AIDI Biomedical, LLC implants and abutments are made out of medical grade titanium alloy which is biocompatible.

Surface Treatment:

IDI implants are blasted with resorbable SBM and then blasting medical residue is removed from the implant (ASTM F86-4 standard).

Caution:

The sale of this device is restricted to, or by the order of, licensed physicians or dentists.

Manufactured by:

AIDI Biomedical, LLC

34859 Frederick St. #105

Wildomar CA, 92595 USA

http://www.aidibiomedical.com

I.D.I.牙种植系统属于骨内种植体，意在上下巴骨上实施手术以便它能支持修复性的植体，比如人工牙，从而修复患者的外观自然美及咀嚼咬合功能。

零角度牙基台意指不仅螺旋保留着而且包括了胶结修复。这种牙种植表明它可以是单个的或多个的牙修复并且可应用在有夹板和没有夹板的状况下。

这种装置被设计与用在当好的基础性的稳定达到要求而且是随着适当的大量的装载时实施即刻的放置。