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Product information On
Quadrant FiniSense
Desensitizing primer
Introduction
Dental desensitizing primers such as Quadrant
FiniSense are used in the dental practice to relieve pain caused
by exposed toothnecks or dentine and to prevent or relieve postoperative
sensitivity under all restorative materials.
Quadrant FiniSense
causes coagulation of the proteins in the dentine liquid. The direct
result of this is intradentinal closing of the tubuli, which prevents
movement of the liquid in them - the cause of the sensitivity.
Quadrant FiniSense has a permanent effect when underneath restorative
materials. Pain at the tooth neck disappears for about 12 months.
Quadrant FiniSense
is compatible with all restorative materials and it is available
in 5-ml bottles.
The standard application of Quadrant
FiniSense is as follows:
- Clean the dentin using, for example, pumice slurry.
(Quadrant FiniSense
can be applied without removing the smear layer by etching)
- Carefully dry the dentine surface, the tooth may be somewhat
moist.
(Working with rubberdam is recommended)
- Apply the minimum amount of Quadrant
FiniSense required for the treatment and allow this to work for
30 seconds.
(It is not necessary to use a polymerization lamp)
- Gently blow-dry with a stream of air, until the liquid disappears
and the surface no longer shines.
- Rinse thoroughly with water.
Quadrant
FiniSense is developed and manufactured by Cavex Holland B.V.,
a Company that is certified according to the provisions of the
Council Directive 93/42/EEC of 14 June 1993 concerning
Medical Devices, against ISO 9001 and ISO13485.
Quadrant
FiniSense bears the CE-Mark of conformity.
Composition
The basic ingredients of Quadrant FiniSense are:
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Quadrant FiniSense
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2-Hydroxyethylmethacrylate
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36
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% w
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Glutardialdehyde
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5
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% w
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Water
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59
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% w
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Manufacturing
Basically, all ingredients are carefully weighed and blended.
Laboratory control
At present, a product standard for desensitizing primers is not
available. Therefore, quality control is carried out according to
a number of in-house standards.
Shelf-life test
There is no official shelf-life test described for composite resins,
bonding agents or desensitizing primers. But it is well known that
dental materials may show some deterioration upon storage, in particular
at elevated temperature. Therefore, care should be taken to protect
the product from a decrease in quality.
Extensive shelf-life studies have been carried out at different
temperatures, recording any change in product qualities related
to storage conditions.
Based on the results of these tests, we can guarantee the good
qualities of Quadrant FiniSense
for a period of 3 years, provided the product is stored in a refrigerator
when not in use.
Quality control
A batch of Quadrant FiniSense,
that has passed all the tests, is released for sales. In case of
one or more requirements being not in specification, that batch
is withdrawn and not sold.
Statement of non-toxicity
We hereby declare that Quadrant FiniSense can be safely used and is nontoxic to the dentist,
the dental assistant as well as to the patient.
Quadrant FiniSense
will also normally not be irritant to oral tissues. Quadrant FiniSense does not contain any
poisonous ingredients in sufficient
concentration to be harmful to human beings, when used as directed.
Haarlem
CAVEX HOLLAND B.V.
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