1. Intended Use

This product is connected to fixture and using for support prosthetic restoration of lost tooth. It is a disposable medical device.

2. Cautions ① Use once, only by skilled dentists. ② Check the validity date and package condition. ③ A consensus between the surgeon, dentist and technician is needed in order to determine the oral cavity condition and make a treatment plan.

④ Make a plaster cast after taking an impression model of the maxillar and mandibular bite surface.   ⑤ Cover screw or healing abutment is placed in the patient’s mouth until osseointegration occurs.

 

3. Contraindications

-. Intra-oral contraindications Inadequate inter-occlusal connection (insufficient bone quantity), malocclusion, chronic condition of the alveolar bone, jaw radiation therapy, dry mouth, chronic changes of the oral mucosa (leukoplakia, lichen planus, stomatitis), macroglossia, unrestored tooth, poor oral hygiene.

-. Temporary contraindications Acute inflammatory disease and infection, pregnancy, temporary use of specific medication(anticoagulant, immunodepressant), physical or mental stress

-. Mental contraindications Uncooperative patients, alcohol and drug abuse, neurotic or psychotic patients

 -. General medical contraindications Current medication (Corticosteroid, long term antibiotic treatment), Metabolic disorder (Juvenilediabetes, blood sugar level(higher than 300), Hematologic disorder (RBC, WBC, coaggulation system disorder), Metabolic disorder of bone (Osteomalacia, osteitis deformans, osteogenesis imperfecta, menopausal osteoporosis), Collagen disorder (Dermatosclerosis, rheumatic arthritis), Implant as focus of potential bacterial growth (Artificial heartvalve, bacterial endocarditis

 

4. Side effects

Dehiscence, Delayed healing, Paresthesia, Hyperesthesia, Edema, Hemorrhage, Hematoma infection, Inflammation, Allergy, Pain, Paralysis, Neuropathy, Peri-implantitis.

 

5. Direction

 -. Preparations before use ① After the fixture is implanted, top with cover screw and wait for the healing period for osseaintegration. (3 to 6 months) ② After the healing period, remove the cover screw through a general surgery procedure then fasten the healing abutment to determine the position of the prosthesis. ③ Wait for the soft tissue healing period.

-. Directions for use ① After soft tissue is healed, take impression using impression material; in cases of one-stage surgery, take impression after removing the healing abutment. ② The type and size of the abutment is determined by taking an x-ray, impression and its relation to the adjacent tooth.

③ Since this product is not sterile, it should be sterilized before installation to mouth. Autoclave should be used, not longer than 30 minutes at in 121℃. ④ Set the abutment in the patient’s mouth. ⑤ Take the final impression in the mounted abutment. ⑥ Select the abutment. If it’s the cemented type, wax up the abutment then make the restoration. ⑦ After the prosthesis is mounted on the abutment, check the occlusion of the upper and lower teeth surface. ⑧ Recommended torque is 30-35N·cm when connecting abutment with fixture. ⑨ Recommended torque is 8-10N·cm when connecting healing abutment and cover screw.

 -. Not reusable. Do not use more than once.

 

6. Preservation

① Store in cold shade, well-ventilated room with temperatures of 12~28°C with humidity of 0~80%. ② Do not store in areas with chemicals, gas and infection.

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2024.01.18 ver. 9