Contents
02
How to use & Notice
03
Test Result 01
06
Zionics TS Type
16
Zionics SuperLine Type
25
Test Result 02
30
Zionics UF Type
41
Zionics IS Type
50
Zionics Tissue Level Type
58
Zionics Bone Level Type
61
Zionicsl Branemark Type
68
Overdenture ZM LOCK
72
Instrument
How to use & Notice
How to use
A. Preparation before use
1) The results of X-ray imaging should be read well and the product should be
selected according to the patient’s characteristics.
2) Check the deformation of external shape, discoloration, attachment of foreign
matter, damage status about the product.
3) All surgical instruments used must be sterilized in advance. Sterilization time
should be sterilized for at least 15minutes at 135°C or at least 30minutes at
120°C. (ISO 17665-1,2)
4) When placing the upper structure in the patient’s mouth, the
surgeon proceeds with the procedure after checking the osseointegration of
the implanted fixture by radiographic by radio
graphic photograph, tapping reaction etc.
5) The surgeon should be fully familiar with the operation method
using the surgical instrument of this product, clinical indications,
cautions.
6) Check the patient’s oral condition to make sure that there are
no biological or biologic factors that may interfere with the surgical outcome.
7) After implanting the implants ,tighten the cover screw or the
healing abutment, wait for a certain period of healing for the
osseointegration. After a certain of time, remove the cover screw through the
surgical procedure and wait for healing of soft
tissue by attaching the healing abutment to the upper part of
the implant for positioning of the gums and positioning of prostheses.
Because there are various kinds of abutment, establish
a prosthetic manufacturing plan after the sizes and type of
prostheses are determined according to the patient’s oral
condition.
B. How to Use and Order of Operation
1) After the soft tissue is healed, the impression is obtained.
(In case of One Stage Surgery, the impression can be obtained
immediately after removing the Healing Abutment.)
2) The type and size of the abutment are selected by comparing
with the X-Ray shooting and impression obtained, considering
the relationship with adjacent teeth.
3) Since this product is a non-sterile product, it must be used
with vaporization before mounting it in the mouth of the patient.
(The sterilization method is in accordance with ISO 17665-1, 2)
4) Mount the selected abutment in the mouth.
(Applies screw to retained type)
5) After obtaining the final impression while the abutment is
mounted, assemble the healing Cap on the abutment to protect the screw
and the abutment.
6) In case the selected abutment is the Cement retained type,
prosthesis is manufactured by using the gypsum mode after
waxing up on the abutment.
7) After mounting the first prosthesis on the implant or abutment
in the mouth, and check the joint between the upper and lower
parts by fastening the screw.
C. How to store and manage after use
It should be stored at room temperature and should be kept away from damp or humid places.
Precautions for Use
A. Precautions for Use
(Cautions for health conditions, etc. considering the characteristics of medical devices)
1) In-mouth taboos
① Inadequate terms and conditions
(inadequate amount of bone)
② Questionable occlusion or functional relationship
③ Pathological condition of the pubic bone
④ Radiation treatment in the weak bone
⑤ Oral driedness
⑥ Pathological changes of the oral mucosa
(Vitiligo, Lichen planus, stomatitis)
⑦ Tongue hypertrophy
⑧ teeth, poor oral hygiene
2) Temporarily restricted taboo
① Acute inflammatory disease and infection
② Pregnancy
③ Temporary use of certain medications
(anticoagulant, immunosuppressant)
④ Physical and mental stress conditions
3) Mental taboos
① A patient with poor cooperation
② Alcohol and Drug Abuse
③ Neurology, psychopath
④ Problematic patient
4) General medical taboos
① General and nutritious condition-age
(Obesity, weak constitution , viability more than 5 Years)
② Current drug use(steroids, long-term antibiotic therapy)
③ Metabolic disorder(puberty diabetes, diabetes level300 or more)
④ Hematological disorders (red blood cells, white blood cells,
and blood clotting system disorders)
⑤ Heart and circulatory diseases (Aortic hardening, high blood
pressure level of 300 or higher)
⑥ Metabolic disorders of the bone(Osteomalacia, Paget disease,
osteogenesis imperfecta,osteoporosis of menopause)
⑦ Collagen disorder (dermatosclerosis, rheumatoid arthritis)
⑧ Implants as a focal point of potential bacterial growth
(artificial heart valves, bacterial endocarditis)