XC
Connection
2.5 Hex fastening Type of 11 degree. Morse Taper Type
Dual Thread
As 0.8 Dual Thread Type, the placing speed is very fast.(1.6mm
per 1 rotation)
Main Thread
When the fixture is inserted into the implant bed, the conical
shape and lower deep thread of the fixture increase stability and make
immediate loading possible.
RBM Surface
Surface areas are increased through blasting by highly biocompatible
Calcium- Phosphate Media.
Cutting Edge
When placing the implants, the cutting edge of the Twist Type
increases Self Tapping ability and minimizes Bone resistance.
Apex
As a structure of D (Diameter) - 0.7mm, the overall Tapered type
INSTRUCTIONS FOR Xcem Classic (XC)
Purpose of product
This product use an artificial tooth root inserted
into the upper or lower alveolar bone in dental implant surgery.It is a
disposable sterilized medical device.
1.
Cautions
of use
-
General
cautions
·
Use
only skilful dentist, use only one time.
·
Check
the term of validity and the package condition.
·
The
implantation procedure should be done under aseptic condition, care for contamination.
·
Surgery,
dentist and dental technician make a surgical plan by discussing to accurate
examination of patient’s condition.
·
Care
for pyrexia and injury.
-
Cautions
of use
·
The
accompanying label for medical treatment should be used for care of patient.
·
Maximize
revolutions per minute of Torque Controlled Hand – piece is 1.5.
·
Recommended
torque is 10N/cm² when connecting healing abutment or cover screw.
·
Cleaning
around surgery part.
·
After
surgery, supply surgery part with saline.
·
Must
not use except mentioned purpose.
-
Cautions
during healing period
·
Cleaning
oral for saline.
·
Let
him bite the gauze for control bleeding during 1 hour
·
Check
a mucous membrane every 3-4 week after insertion and check a panorama before
connection abutment.
·
To
avoid inflammation and infection, proper maintenance on hygiene of oral is
essential.
·
Educated
on prevent of overpressure in healing period.
2.
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), Hemotologic 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).
3.
Side
effects
Dehiscence, delayed healing,
Paresthesia, Hyperesthesia, Edema, Hemorrhage, Hemotoma, Infection,
Inflammation, allergy.
4.
Directions
-
Matters
to prepare before use
·
Open
package after checking package condition and expiration date before use of
product, and use it in surgery after checking any damage or problem of product.
·
Dentist
should fully understand operation sequence and direction by using surgical
instrument of the product before clinical use.
·
Prepare
to sterilized surgical instrument for surgery (121°C x 30min : Autoclave)
·
Surgery,
dentist and dental technician make a surgical plan by discussing to accurate
examination of patient’s condition.
-
Directions for use
·
Open
outer box after checking information of label. First check instruction for use.
·
Remove
packaging film.
·
Open
cap of inner ampule, pull out carefully inserted fixture.
·
Hold
on cap of inner ampule and placed hand-piece or rachet wrench of connected
fixture driver on inner hexa or octa of fixture.
And
then tilt a fixture open side, broke a bottom neck of fixture.
·
Assigned
range of torque should apply when fastening screw of abutment. And completely
cleaning around implant after connected abutment in fixture.
5.
Storage
and handling after use
Use only one time. Do not reuse.
6.
Healing
period after inserted implant
7.
Patient
should be informed of matters that require attention until next appointment.
8.
Let
the patient visit every week 3 ~4 weeks during healing period.
9.
A
stitch out is done after 8 ~9 days and surely checks infection or remained
suture
10.
Preservation
·
12° ~ 28° and 0 ~ 80% in cold shade and well ventilation room.
·
Avoid
in room of chemicals storage, gas issues and fearing infection.
3 years in not opened
after sterilization.