Instructions for Use, Dental Implants
General:
Before using a DMi’s Dental products, the operating surgeon/ practitioner in charge should carefully study the indications, contraindications, recommendations, warnings and instructions, as well as all other product-specific information (product description, description of the surgical and restorative technique, catalogue, etc.) and fully com- ply with them. DMi also recommends attending the appropriate user-training courses, conducted locally and remotely by authorized DMi specialists. The aforementioned documents and details of the training courses may be obtained from the respective representatives in the various countries and from the company website www.dmimplant.online
Disclaimer:
DMi, the importer and suppliers of DMi products shall not be held responsible for complications, other negative consequences or damages that may arise due to reasons such as incorrect indications or surgical technique, improper material selection or handling, improper use or handling of instruments, etc. The operating surgeon is responsible for any such complications or other consequences. It is also the responsibility of the operating surgeon to properly instruct and inform the patient about the function, handling and necessary care of the device, as well as any known risks associated with the device.
Product Description
The DMi sterile Implant Kit contains:
-PRTI, UTI, PFTI, SMI – implants with the implant holder and the cover screw;
-UMI, PMI, NTI, ITI implants with the titanium abutment and cover screw;
-STI implants with the implant holder.
All implants are self-tapping, conical, external spiral thread and internal thread 1-72UNF.
The implant is made of titanium alloy TI6AL4V according to the ASMS F136 standard.
Implant types PRTI, UTI, PFTI, NTI, ITI have internal hex connection H2.43mm & H2.1mm. Implant types UMI, PMI have internal conical connection CH2.43mm & CH2.1mm. SMI implants have external hex connection. STI implants are one piece with the abutment. The set is γ-sterilized.
Intended use, indications for use:
DMi dental implants and related prosthesis parts are intended for use in surgical and restorative applications to be placed in the bone of the upper or lower jaw, in the area of missing teeth, to provide support for prostheses such as artificial teeth, to restore the patient’s masticatory function, aesthetics, etc.
CONTRAINDICATIONS
The conditions listed below may contribute to a lack of integration and/or subsequent rejection of the implant. It implies the presence of diseases and certain conditions of the body, when surgical intervention poses an obvious risk to health, as well as in the presence of incurable diseases that make it impossible to achieve positive results of implantation. These include:
• Chronic diseases in the stage of decompensation.
• Systemic disorders of bone metabolism disorders.
• Uncontrolled bleeding disorders.
• Immunodeficiency, AIDS and any other seropositive infection.
• Mental illness.
Relative contraindications or risk factors
Relative contraindications are diseases that create certain difficulties in achieving the predicted result, statistically reduce the effectiveness of implantation and may lead to treatment failure.
Risk factors include an unfavorable anatomical condition of the hard and soft tissues of the jaws, osteolytic, inflammatory or infectious activity in the implantation zone, deformity of the bite and dentition, bruxism and diseases of the oral mucosa requiring additional surgical interventions or non-standard approaches to treatment.
Risk factors are:
• Wrong lifestyle, intellectual and emotional status.
• Acute and chronic diseases in the stage of compensation.
• Pathologies in which homeostasis can be stabilized or compensated.
• Changes in the organs and systems of the body due to modern methods of treatment.
• Acute inflammatory diseases and acute viral infections.
• Infections of the oral cavity
• High risk of bacteremia (patients with prosthetic heart valves and past bacterial endocarditis, rheumatism).
• Patients with heart and lung disease, especially those who have recently had a heart attack or stroke.
• Pregnancy and lactation.
• Treatment with drugs that impair tissue regeneration: immuno- suppressant, hormonal, etc.
• Young people under the age of 21
• Osteopathic diseases: osteoporosis and osteomalacia.
• Uncontrolled systemic diseases that violate osteogenesis: diabetes mellitus, diseases of the thyroid or parathyroid gland and pituitary gland, pathology of the adrenal glands, blood diseases such as hemophilia, granulocytopenia or other blood clotting disorders; Ehler-Danlos syndrome, bone-beam necrosis, renal failure, organ transplantation, fibrous dysplasia, regional enteritis.
• Alcoholism and drug addiction.
• Systemic connective tissue diseases: systemic lupus erythematosus, dermatomyositis, Siegen’s syndrome, a group of congenital systemic connective tissue diseases inherited in an autosomal dominant manner: Kind’s, Gerley’s, Meknes’s syndrome, Gauthier’s dis- ease, Niemen-Pick syndrome, various types of congenital dysplasia and dysostotic.
• Allergy or hypersensitivity to the chemical components of the materials used.
Risks and complications:
Risks associated with the surgical procedure may include Unintentional sinus perforation, local and systemic infections, and nerve damage. Temporary conditions may include pain and swelling, speech problems, and gingivitis. Long-term problems may include nerve damage, localized bone loss, hyperplasia, local or systemic bacterial infections, and endocarditis.
1. Risks and complications associated with the surgical procedure may include:
- Temporary or permanent nerve damage;
- Temporary or permanent violation of the mobility of the facial muscles;
- Local, temporary, or permanent disturbances of sensitivity;
- Infections, sinusitis;
- bleeding;
- Local pain, pain in neighboring teeth;
- Edema;
- Problems with speech;
- Difficulty swallowing;
- Inflammation and swelling of the gum mucosa;
- Loss of jawbone and gums;
- Loss of implant integrity, implant mobility, implant loss.
2. Risks and complications associated with implant prosthetics may include:
- Pain when chewing;
- loosening of abutment screws, unscrewing and loss of forming abutments;
- Loss of fixation and loss of prosthesis design on implants;
- Fracture of the prosthesis design;
- Fracture of abutments and screws;
- peeling of ceramics from the design of the prosthesis;
- Violation of the fixation of removable structures on implants;
- Hypo or hypertrophy of the gums;
- Peri-implantitis;
- Inflammation of the gums;
- Bad breath, dry mouth;
- Loss of implant integrity;
- Mobility of the implant;
- Loss of implant and prosthesis design.
Precautionary measures
DO NOT RE-STERILIZE!!
1. Implant kits/sets are for single use only. Partially opened, damaged or defective packages are returned to the supplier for free replacement. Do not use implant kits/sets after the expiration date. Open the sterile packaging and remove the implant only to a clean, sterile surface. Avoid any contact with non-sterile or contaminated surfaces after removal from packaging. Work only with non-metal tweezers or titanium instruments. Never reuse an extracted and/or rejected implant.
2. All non-sterile materials, parts, and instruments must be cleaned, disinfected, and sterilized according to appropriate instructions before entering the patient’s mouth.
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 auto-clave 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 be- fore date, etc.) which are to be affixed on the patient file.
The implant kits, prosthetic parts and accessories are shipped only in the original cardboard box inside of good hardcover package. Store at 10°C to 30°C. If the inner or outer packaging is damaged, do not use the product, contact the DMI representatives.
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 the durability of the installed dental implants and prosthetic parts on them depends on adherence to the doctor’s recommendations and the implementation of these recommendations by patients.
The practitioner informs the patient of the potential unwanted effects consecutive to the dental implant placement: refer to the list of Risks and complications above.
Patient’s written 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.
Warranty
1. All DMi Technology L.L.C. products are guaranteed to be free from defects in material and workmanship at the time of shipment. All our products are designed and manufactured to meet the highest quality standards. We accept no liability for failure of products which have been modified in any way from their originals, for any failure due to misuse or application which is not in accordance with the designer’s intentions.
2. DMi dental implant is used in conjunction with specific related prosthetic parts and accessories manufactured by DMi. All DMi prosthetic components are mutually compatible. They must not be substituted by parts not manufactured by DMi. Any use of prosthetic material and/or ancillary not validated by DMi will void the manufacturer’s warranty.
3. DMi Invasive and implantable parts are single-use devices and must not be reused. Any re-use of a single-use device induces a significant risk of infection for the patient. Any re-use of single-use devices will void the manufacturer’s warranty.
Defective or partially open packages should not be used.
Do not use implant kits / sets after the expiration date.