INTRODUCTION FOR USE (ABUTMENT)

        1.      Purpose of product

This product is connected to fixture and for support prosthetic restoration of lost tooth.

It is a disposable sterilized medical device.

2.        Cautions of use

-          General cautions

·          Use only skilful dentist, use only one time.

·          Check the term of validity and the package condition.

·          Surgery, dentist and dental technician make a surgical plan by discussing to accurate examination of patient’s condition.

·          Making a plaster cast after taking impression model by occlusion with upper and lower surface.

·          Taking on cover screw or healing abutment in mouth of a patient until osseointegration.

3.        Contraindications

-          Intra-oral contraindications

Inappropriate inter-occlusal relationship (insufficient bone quantity), problematic occlusion or functional relationship, pathologic condition of alveolar bone, radiation therapy on alveolar bone, xerostomia, pathologic change of oral mucosa (Leukoplakia, lichen planus, stomatitis), Macroglossia, Unrestored tooth, poor oral hygiene.

-          Contraindications that is transiently limited

Acute inflammatory disease and infection, pregnancy, temporary medication of specific medicine (Anticoaggulant, immunodepressive), physical or mental stress.

-          Mental contraindications

Patients with poor cooperation, alcohol and drug abuse, neurotics, patients with mental illness.

-          General medical contraindications

Current medication (corticosteroid, long term antibiotic treatment), metabolic disorder (juvenile diabetes, 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.        Directions

-          Matters to prepare before use

·          Healing period for osseointegration is 3-6 months after inserted fixture .

·          Remove cover screw and connect healing abutment after healing period for osseointegration.

·          Waiting for healing period of soft tissue.

-          Directions for use

·          After soft tissue is healed (In one stage surgery, it is possible right after removing healing abutment), take impression with impression material.

·          Type and size of abutment is decided by X-ray taking impression and relationship of adjacent tooth.

·          Since this product is not sterile, it should be sterilized before installation to mouth. Autoclave in dental clinic is used and it should be longer than 30 minutes in 121°C

·          Setting of abutment in mouth.

·          Taking final impression in installation abutment.

·          If selected abutment is cemented type, wax up the abutment by plaster cast, so make restoration.

·          After restoration take on fixture or abutment in mouth, check occlusion with upper and lower surface.

·          Recommended torque is 30-35N/cm² when connecting abutment with fixture.

·          Recommended torque is 8-10N/cm² when connecting healing abutment and cover screw.

-          Storage and handling after use

Use only one time. Do not reuse.

5.        Preservation

·          12°C   ~ 28°C and 0   ~ 80% in cold, shade and well ventilation room.

·          Avoid in room of chemicals storage, gas issues and fearing infection.