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ISO 4049 – Dentistry – Polymer-based restorative materials

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ISO

Les titres, résumés et légendes des publications sont présentés en anglais.

This International Standard specifies requirements for dental polymer-based filling and restorative materials and polymer-based luting materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of cavities in the teeth. The following section of the standard can be performed using an uniaxial Mach-1 mechancial tester.

Flexural strength
Section 5.2.9 (Flexural strength, type 1 and type 2 materials) of this standard specifies that the flexural strength of type 1 and type 2 materials shall be equal to or greater than the limits specified in the following table.
Minimum flexural strength
Type 1 Class 1 80 MPa
Class 2, group 1 80 MPa
Class 2, group 2 100 MPa
Class 3 80 MPa
Type 2 Class 1 50 MPa
Class 2, group 1 50 MPa
Class 3 50 MPa

As per section 7.11 , the flexural strength test is conducted on a 2x2x25 mm3 molded sample under a 3-point bending configuration (3 rods, 2 mm in diameter, bottom rods spacing of 20 mm between centers) with a constant crosshead speed of (0,75 +/- 0,25) mm/min or a rate of loading of (50 +/-16) N/min. 
Measurement of film thickness of luting materials
As per section 7.5 of the standard, immediately after mixing material, a certain material volume (between 0,02 mL and 0,1 mL of the test material) is squeezed between 2 glass plates up to a loading of 150N. The thickness of the resulting film is measured with a 1 micron precision and must be under 50 microns (some criteria applies).

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