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■ Product Name

  • · Common/Usual Name : Dental Implant System
  • · Product Name : Dental Abutment set
  • · Brand Name : MEDIDEN Implant system

■ Description

  •     The Mediden implant system supports prosthetic devices such as artificial teeth, and consists of materials related to shifts, surgery, and prosthetics. This product is a dental fixation device and a prosthesis that is surgically placed on the bones of the upper or lower jaw arch to restore the patient's chewing function.

■ Intended For Use

  •     The Mediden implant system is an implant replacement that is inserted to support an implant such as an artificial tooth with an implant superstructure. This implant is used to restore the patient's chewing function.

■ Intended For Use

SIZE SHAPE IMPLANT SYSTEM SIZE SHAPE IMPLANT SYSTEM
1 Abutment ELI Titanium-6-Aluminium-4 Vanadium Alloy ASTM F 136 100% oral mucosa And tooth contact
2 Abutment Screw ELI Titanium-6-Aluminium-4 Vanadium Alloy ASTM F 136 100% oral mucosa And tooth contact

■ Precautions before use

  • ① Check if the product is the same as the product that you want to use
  • ② Visually check the product for damage or impurities, etc.
  • ③ Check if the appearance or shape of the product is suitable for use.
  • ④ Never use it except for trained doctors and authorized personnel.
  • ⑤ Since it is not sterilized, use high-pressure steam sterilization (1.5 barometric pressure 121°C/30 minutes in AutoClave) before installing it in the mouth.

    ※How to sterilization

  •       Since this is a non-sterilized medical device, you should sterilize it through autoclave method before use. Standard for the autoclave : autoclave at 121℃, pressure of 1.5 for 30 minutes.
  •       ① Supply power to the autoclave.
  •       ② Place the product in the autoclave.
  •       ③ Set the autoclave. (Temperature: 121 degrees, time: 30 minutes)
  •       ④ When finished, take out the product.

■ How to Use

  • ① After the soft tissues are cured, use the impression materials to take an impression.
  • ② Compare the impression and X-Ray image. Select the type and size of abutment considering the relationship with adjacent teeth.
  • ③ Process it using a CAD/CAM system milling device. (parts that are milled to suit the patient's oral condition. When the external diameter of the finished product is ∅4.0 or higher, the length shall be not more than 7.3mm, and when the external diameter of the finished product is ∅3.5, the length shall not exceed 5.0mm
  • ④ Attach the processed abutment in the mouth.
  • ⑤ Cut the attached abutment to an appropriate length to modify its shape.
  • ⑥ Take the final impression from the modified abutment and manufacture the final prosthesis. The plastic post will be burnt out on the casting process.
  • ⑦ After mounting the final prosthesis on top of graft or abutment in the mouth, the screw is connected and occlusion between upper and lower jaws is checked for completion.

■ Storage and management methods after use

  • Do not reuse as a disposable medical device, and discard used products.

■ Precaution

  • ① When attaching the upper structure to the patient's mouth, the degree of bone fusion of the eaten fixture must be verified by X-ray images and ossification reactions before proceeding with the procedure.
  • ② After acquiring the impression body in consideration of the mating faces of the upper and lower parts, a gypsum model is produced. The gypsum model shall be sent with the upper component set which is intended to be mounted as a workpiece for the manufacture of prosthetics.
  • ③ Before installing in the mouth, sterilize devices and surgical instruments with high-pressure steam (1.5 barometric pressure 121°C/30 minutes at AutoClave).
  • ④ After tightening, thoroughly clean the tank to prevent any impurities from remaining.
  • ⑤ It is not used for any surgical procedure other than for use purposes.
  • ⑥ Single use only, does not reuse.
  • ⑦ Do not re-sterilize.

■ Contraindications

  • Implant procedures should be considered when:
  •     - Patients with problems with maxillary and mandibular occlusal function
  •     - In case of acute inflammatory disease or infection.
  •     - Leukemia, hemophilia, thrombopenia.
  •     - Hemorrhagic disease
  •     - Patients who have been taking the drugs(osteoporosis, diabetic) for a long time.
  •     - Alcohol dependence, depression, schizophrenia.
  •     - Radiation therapy on jaw.
  •     - tongue hypertrophy
  •     - Oral mucous membrane abnormality (Vitiligo, Lichen planus, Stomatitis)
  •     - Oral dryness
  •     - In the case of keloid

■ Warning

  • - Since product damage and surrounding bone tissue damage can occur, the product should be used only by an experienced clinician.
  • - This product should not be reused and should be applied according to the correct use and purpose.
  • - Defective products should not be used.
  • - Improper selection of the implant or unstable location and fixation of the implant may shorten its life.
  • - It is not used for any surgical procedure other than for use purposes.
  • - This product should not handled carefully to prevent production damage and deformation.
  • - If patients suffer from any incident or adverse event with regard to the device, they must report it to the manufacturer, European Authorized Representative and competent authority.

■ Indication

  • - t was designed for dental implant surgery, it is placed on the maxillary or mandibular alveolar bone through a surgical operation to replace the dental root.

■ Side Effect

  • - Symptoms of dehiscence, temporary hypersensitivity reaction, delayed healing, edema, hematoma, gingivitis, and bleeding may occur in certain areas.
  • - The jaw in the mandibular procedure, and the tissue next to the nose in the maxillary procedure may cause side effects. Most of them appear temporarily, but very rarely, permanent paralysis can occur.
  • - Gingival tissue ulcers and infection of cellular tissues may occur.
  • - Loss of implant stability, loss of prosthesis, etc.
  • - Deficient quality and quantity of remaining bone, implant mobility, partial deterioration of tissue, and improper position and arrangement of implants can cause instability.

■ Caution

  • - The product cannot be used if the packaging is open or damaged.
  • - Products contaminated by the operator's mistake during the procedure cannot be used
  • - All products used in the oral cavity are disposable, so do not reuse.
  • - Do not use this product for patient with metal allergy.

■ User populations

  • 1) Education: Degree of Dental of Doctor
  • 2) Knowledge: Implant treatment education.
  • 3) Language Understanding: English, Korean
  • 4) Experience: Have Implant treatment experience
  • 5) Permissible impairments: Should be used by dental of doctor. It is medical device for dental use.

■ Patient populations

  • - Age: Not applicable
  • - Body weight: Not applicable
  • - Health: There are no special requirements, but the following patients are not allowed using
  •     · Infectious skin disease
  •     · Oral dryness
  •     · In the case of keloid
  •     · Hemorrhagic disease
  •     · Uncontrolled diabetic complications
  •     · Pathological changes in oral mucosa (vaccination, squamous tae-sun, stomatitis)
  •     · Allergic for metal
  •     · Radiation therapy on the scrotum
  •     · The pathological condition of the pubic bone
  •     · A problematic mating or functional relationship
  •     · Inadequate correlation (inadequate amount of bone)

■ Storage Method

  • at 4~25 ℃

■ Disposal

  • For disposal, country specific laws and regulations must be observed.℃

■ Shelflife

  • 10 years if there are no problems with storage conditions and packaging conditions.℃

■ Warranty

  • ① Safety Instructions :
  •     Responsibility for proper cleaning, disinfection and sterilization of products is the sole responsibility of the operator / product user.
  • ② National regulations including limitations must be carefully followed.
  • ③ All our products are designed and manufactured to meet the highest quality demands.
  • ④ The manufacturer of the products excludes any warranty claims and assumes no liability for direct or consequential damage as a result of:
  •     - Misuse
  •     - Improper use, application or handling
  •     - Improper preparation and sterilization
  •     - Improper maintenance and repair
  •     - Failure to observe the Instructions for Use
  •     ※ This product is a non-sterile medical device

■ Label Symbols

Symbol Description Symbol Description
Reference No.
Catalog No.
 Refer Instruction For Use
Lot. No. Disposable
Storage temperature Do not use
If package is damaged
Manufacture Date Non-Sterile
Manufacturer European Authorized
Representative
Caution CE mark (NB : 2764)