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Dental Wax Sheets by Cavex®

Complete product information about these waxes



Chinese




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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