Product Description

The SMART implant system is a comprehensive product line that includes surgical

parts, prosthetic instruments, corresponding abutments, and closure screws.

SMART dental implants are designed from biological materials that the human body

recognizes for maximum bone anchorage. These are grade 23 titanium (Ti 6Al-4V ELI)

implants that have undergone thorough large-grit sandblasting. To maintain implant

integrity, the implant should be inserted within 15 minutes after removal from package.

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Indications for Use

The SMART system is intended for use in the upper or lower jaw by treatment of

endosteal implantation. This allows for the esthetic and purposeful oral rehabilitation,

specifically for partially dentate and edentulous patients, unless otherwise specified.

Following loss or extraction of natural teeth, SMART Implants may be used for

immediate or early implantation. In order to restore chewing capabilities, implants

may be placed for single or multiple tooth applications, through initial primary stability

and satisfactory occlusal loading. SMART prosthetic restorations are connected to

the implants by their corresponding abutments. These restorations include: fixed and

removable partial and complete dentures, as well as single crowns.

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Limitation of Liability

Simple, the importer and the suppliers of our products are not liable for complications, other negative effects or damages that might occur for reasons such as incorrect indications or surgical technique, unsuitable choice or handling of material, unsuitable use or handling of the instruments, etc.

The operating surgeon is responsible for any such complications or other consequences. It is also the operating surgeon's responsibility to properly instruct and inform the patient on the functions, handling and necessary care of the product and on all known product risks.

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Implant selection

Be aware that SMART implant defines by its diameter, total length and the length of the thread.

Please refer to the catalog for surgical technique.

 

Manufacturer:

SIMPLE Implants LTD.

13b Kehilat Odessa St. Tel-Aviv, Israel, Link

 

INTENDED USE AND INDICATION FOR USE

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Simple Dental Implants and related prosthetic parts are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Prerequisite:

• Adequate bone to support the implant with width and height

• Maxillary and Mandibular y arch locations

• Completely or partially edentulous patients

 

CONTRAINDICATIONS AND RISKS

The conditions listed below may contribute to lack of integration and/or subsequent implant failure.

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Absolute contraindication to implantation

This implies the presence of diseases and certain conditions of the body when surgery is an obvious health risk, as well as when there are non-treatable diseases that make it impossible to achieve positive results of implantation. These include:

• Chronic diseases in the stage of decompensation (weakened immune system, serious internal medical problems and et.)

• Systemic disorders of coagulation (bone metabolism disturbances)

• Uncontrolled bleeding disorders.

• Immunodeficiency, AIDS and any other seropositive infection.

• Psychological instability or diseases (uncooperative or unmotivated patient)

• Drug or alcohol abuse

• Allergies or hypersensitivity to chemical ingredients of materials used: in case of known allergic reactions to metallic part, a preliminary test is recommended.

• Patients receiving treatment with cyclosporine, azathioprine or similar, corticoids, anticoagulants or bisphosphonates

 

Relative contraindication or risk factors

Unless augmentation can be considered, the implants should not be placed if insufficient alveolar bone volume could support it (minimum 1mm circumferential, 2mm apical).

Implants placed in the maxilla should not perforate the sinus floor membrane.

Surgical intervention represents an obvious health risk. However, relative contraindications are only diseases that create certain difficulties for achieving the predicted result, statistically reduce the effectiveness of implantation and can lead to unsuccessful treatment.

Risk factors include unfavorable anatomical conditions that require additional surgical interventions or non-standard approaches to treatment, as well as lifestyle, patient's age, intellectual level and emotional status, acute and chronic diseases, and pathologies in which homeostasis can be stabilized or compensate, changes in the organs and systems of the body due to modern methods of treatment. These include:

• Patients whose implanted site are under osteolytic, inflammatory or infectious activity.

• Abnormal laboratory values for BUN, creatinine, or serum calcium

• Patients with hypertension above 170/110; Patients with respiratory diseases, infections.

• Acute inflammatory diseases and acute viral infections, oral infections

• Chronic infectious diseases (tuberculosis, actinomycosis, etc.)

• Chronic diseases in the stage of compensation

• High risk of bacteremia (patients with prosthetic heart valves and endured bacterial endocarditis, rheumatism).

• Patients with cardiac and lung diseases, especially those who only recently suffered heart attack or stroke.

• Pregnancy and lactation.

• The heavy consumption of tobacco is associated with the increase in the loss of dental implants; failure rate around 2.5 times higher in patients who smoke is reported.

• Treatment with drugs that worsen the tissues regeneration (immunosuppressant, hormonal, etc.).

• Patients with diagnosed malignancies or unexplained lumps or masses in the head or neck: exposure to radiation, chemotherapy may impact the implant health.

• Young people under the age of 21 years

• Osteopathic diseases that adversely affect osteogenesis, osteoporosis-reduction of total bone tissue, osteomalacia - inadequate mineralization of the organic bone matrix with a normal skeletal mass and bone volume

• Uncontrolled systematic diseases that disrupt osteogenesis: diabetes mellitus, thyroid or parathyroid gland and pituitary diseases, adrenal gland pathology, blood diseases such as Hemophilia, Granulocytopenia or other bleeding problems; Ehler-Danlos syndrome, Osseo-radio necrosis, Renal failure, organ transplantation, Fibrosis dysplasia, regional enteritis.

• Alcoholism and drug addiction cause not only mental changes, but also a number of somatic disorders affecting osteogenesis.

• System diseases of connective tissue: systemic lupus erythematosus, dermatomyositis, Siegen’s syndrome, a group of congenital systemic connective tissue diseases inherited by autosomal dominant type: Kind, Gurley, Meknes syndrome, Gautier’s disease, Niemen-Pick syndrome, various types of congenital dysplasia and dysostotic.

• Application of medications reducing blood clotting by patients

• Pathological conditions of maxillofacial area and oral cavity: leukoplakia, stomatitis, caries, xerostomia, periodontitis, macroglossia, malocclusion, temporomandibular joint diseases, gingivitis, periodontitis, peri-implantitis, and unsatisfactory oral hygiene.

• Severe bruxism, clenching, and overloading, may cause bone loss, screw loosening, component fracture, and/or implant failure.

• Incapacity of patient to manage his oral hygiene.

• Bone type 1.

• Poor patient motivation, psychiatric disorders that interfere with the patient understanding and compliance with the necessary procedures. Unrealistic expectations. Unattainable prosthodontic reconstruction. Hypersensitivity to a specific component of the procedure.

 

Treatment of these diseases should be carried out in parallel with implantation, or implantation can be regarded as one of the ways of treatment. If no we can get peri-implantitis, microsites or losing the implant. Please read the Surgical Manual-7.5.5.00.10 Surgical & prosthetic Manual prior to implantation.

 

SMOKING SIGNIFICANTLY REDUCES THE RATE OF SUCCESS

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Risks associated with the surgical procedure may include:

Inadvertent perforation of the nasal sinus, local and systematic infections and nerve injury. Temporary conditions may include pain and swelling, speech problems and gingivitis.

Long-term problems may include nerve injury, local bone loss, hyperplasia, local or systemic bacterial infections and endocarditis. Existing natural dentition may be compromised.

 

Precautions             do not re-sterilize!!

1. The implant kits/sets are for single use only. Partially open, damaged or defective packages are returned to supplier for free-of-charge replacement. Do not use the implant kits/sets post expiration date. Avoid any contact with non-sterile or contaminated surfaces once removed from its packaging. Handle only with nonmetallic tweezers or titanium instruments.

 

Never reuse an extracted and/or rejected implant.

Use only low rotation speeds (3000-rpm max) with externally irrigated drill to avoid excessive heat.

1. All the non-sterile delivered instruments must be cleaned, disinfected and sterilized according to a validated method before entering the mouth of the patient.

2. The SMART implants have not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating, migration, or image artifact in the MR environment. Their safety in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

 

Sterilization

The implant sets and kit are sterilized by 25 kGy γ-irradiation. The instrumentation and the prosthetic components (abutment, attachment ball, healing cap) must be cleaned and sterilized in the autoclave before use for minimum 18 minutes at 134°C. The process of sterilization must be validated by the user according to a method recognized by the authorities of the country of use.

Packaging Condition for use, transportation and storage

Every package, contains the product reference, self-stick labels with all the implant specifications (lot number, sterilization, best before date, etc.) which are to be affixed on the patient file.

The implant kits /sets and the accessories are transported only in the original Cardboard box package inside of good hardcover package. Store at 5°C to 40°C. If the package is damaged do not use it.

Implants and prosthetic parts must be stored in a clean, dry, fresh and appropriate place.

For Surgical Procedure please refer to IFU-7.5.5.00.10 Surgical & prosthetic Manual.

 

Patient Information

The practitioner informs the patient that the safety and/or the durability of the placement of dental implant are function of his/her activity and of the respect for the doctor’s advice.

The practitioner informs the patient of the potential unwanted effects consecutive to the dental implant placement (osseous split, infection, pains, bruise, oedema, temporary or permanent nerve damage, bleeding, oral drought, sinusitis). Patient’s informed consent must be obtained before surgery.

After dental implant placement, the patient will have to inform the practitioner of any sensation or modification appearing at the level of the new dental implant.