
Dental Wax Sheets by Cavex®
Complete product information about these waxes
These waxes are formulated to be high quality premium general purpose
modelling waxes for use in dentistry. Because of the exacting requirements
for quality and reproducibility of product properties in dentistry, these
waxes have found numerous other high technology applications such as in the
electron microscope and histology laboratory.
Introduction
Cavex Set Up Soft, Cavex Set Up Medium, and Cavex Set Up Hard form a series
of waxes for the dentist and dental technician. Their main application is
the construction of the wax rim in which the artificial teeth and molars are
placed in the process of preparing a prosthesis.
The three types: Cavex Set Up Soft, Cavex Set Up Medium, and Cavex Set Up
Hard in particular differ in their flow properties at different temperatures,
thus making the Hard type more stable at higher temperatures than the
Regular or Soft types.
All types: Cavex Set Up Soft, Cavex Set Up Medium, and Cavex Set Up Hard
are tenacious, do not break easily and have exceptionally good handling
properties.
They are presented in the form of red-colored sheets, that can be easily
softened over a flame, or otherwise, and modelled to the desired shape.
Upon cooling, the wax retains its shape with great dimensional stability and
excellent adhesiveness to the other dental materials involved.
Conformity Statements
Cavex Set Up Soft, Cavex Set Up Medium, and Cavex Set Up Hard are developed
and manufactured in a facility certified according to the provisions of the
Council Directive 93/42/EEC of June 14, 1993 concerning Medical Devices,
against ISO 9001 and EN 46001.
Cavex Set Up Soft, Cavex Set Up Medium, and Cavex Set Up Hard bear the CE
marking of conformity for sale in the European Community.
Composition
The basic composition of Cavex Set Up Soft, Cavex Set Up Medium, and Cavex
Set Up Hard is approximately as given in the following Table:
Cavex Set Up
Raw Material Soft Medium Hard
Paraffin waxes
high and low melting, % 63 65 69
Micro-crystalline waxes
high and low melting, % 31 35 25
Natural waxes, % 5 nil 5
Modifiers, % 1 1
Pigment ----- trace amount -----
The various types of paraffins form the basic components of modelling waxes.
In order to obtain the desired properties, the macro-crystalline paraffin
waxes are blended with much softer and more ductile micro-crystalline
paraffin waxes and natural waxes.
Manufacturing
The ingredients are carefully weighted and melted in a kettle. The molten
wax is then homogenized by stirring, the pigment is added and the mixture is
cooled to the desired temperature.
At that temperature, the wax is poured out on an endless belt and cooled
down below the solidification point to form a strip of wax. This strip is
then rolled out between two cylinders, almost like a calendaring operation,
to obtain the desired thickness of 1.5 mm, and individual sheets (18.6x 8.9cm)
are cut off and packed, separated by sheets of grease-proof (in North America,
"wax") paper.
Laboratory Control
At this moment, there is no valid ISO Standard for modelling waxes. All
Cavex modelling waxes comply with the requirements of Type 1 products of ADA
24/24A and ISO/DIS 12163 (1996).
The Cavex testing program consists of the following tests:
1. General inspection of the sheets (color, dimensions, surface smoothness).
2. Working properties (ease of softening over a flame, modelling over a
gypsum-model)
3. Dropping point, which is a fast way of determining the melting
characteristic (ASTM D 566-64).
4. Penetration, which is a measure for the hardness of a wax (ASTM D 1321-65).
5. Congealing point (ASTM D 938-60).
6. Flow (ADA 24a)
For quality control, tests number 1-4 above are carried out on a daily basis
for every batch produced.
Tests number 5 and 6 are carried out regularly, but not on a daily basis.
The following Table gives typical values for Cavex Set Up Soft, Cavex Set Up
Medium, and Cavex Set Up Hard:
Cavex Set Up Test
Soft Medium Hard
1. General inspection
Color and dimensions: comply surface smooth no cracks no gross porosity
2. Working properties Comply Comply Comply
3. Dropping Point 63° C 60° C 61° C
4. Penetration,
unit of 0.1 mm 23 18 17
5. Congealing Point 62° C 58° C 61° C
6. Flow at 23° C 0.6% 0.5% 0.3%
37° C 70% 60% 40%
Note:
The difference between the three types is expressed particularly in the
values for the flow (Test #6), indicating that Cavex Set Up Hard is more
stable at higher temperatures than Cavex Set Up Regular and Cavex Set Up
Soft.
Shelf Life Test
There is no specific shelf life test described for modelling wax. Under
normal conditions, the quality of Cavex Set Up Soft, Cavex Set Up Medium
and Cavex Set Up Hard is hardly impaired upon storage. It is obvious that
storage at too high of a temperature and/or load will lead to blocking
(tendency to stick together) of the wax sheets.
It is therefore recommended that the product should be stored at cool to
moderate temperatures. Prevent stacking the individual boxes too high, in
particular at elevated temperatures or in non-air conditioned environments
in summer or in tropical areas.
Under these conditions, the good quality of Cavex Set Up Soft, Cavex Set Up
Medium and Cavex Set Up Hard is guaranteed for a period of at least 5 years.
Quality Control
A batch of Cavex Set Up Soft, Cavex Set Up Medium or Cavex Set Up Hard,
that has passed all the tests, is released for sale and distribution.
In case of one or more of the requirements not being in specification,
that batch is withdrawn and not sold.
Statement of non-toxicity
The manufacturer states that Cavex Set Up Soft, Cavex Set Up Medium and
Cavex Set Up Hard can be safely used and are non-toxic to the patient as
well as to the dental team or the dental technician.
Cavex Set Up Soft, Cavex Set Up Medium or Cavex Set Up Hard will also
normally not be irritating to oral tissues and do not contain any hazardous
ingredients in sufficient concentrations to be harmful to human beings when
used as directed.
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Monday March 22, 2010
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