0 cytotoxicity data – GC EUROPE Kalore User Manual

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GC Kalore technical manual

Main differences between GC KALORE and GRADIA DIRECT shades

1. changes in terminology:
• Universal shades versus Standard shades.
• Opaque shades versus Inside special.
• Translucent shades versus Outside special.

2. changes in bleach shades:
• KALORE shades OBW and OXBW are same as GRADIA DIRECT BW and XBW shades.
• KALORE BW and XBW are new universal bleach shades with no equivalent GRADIA DIRECT

shade.

3. change in c2 and D2:
• KALORE C2 and D2 have a translucency similar to the other Universal shades. GRADIA DIRECT X

shade c2 and D2 are more translucent.

4. Change in NT and CT:
• KALORE CT and NT are slightly less translucent than CT and NT in GRADIA DIRECT.

8.0 Cytotoxicity data

KALORE was rigorously tested for toxicity of the new monomer (DX-511) using several tests based
on ISO7405 and 10993. All test results were negative for toxicity.

Table 9. Results of cytotoxicity tests with KALORE.

test item

method

Result

Cytotoxicity test

agar diffusion

negative

Sensitization test

Maximization

negative

irritation or intracutaneous reactivity

Oral mucosa irritation

negative

Subchronic systemic toxicity

negative

Genotoxicity

ames, mouse lymphoma

negative

local effects after implantation

1 month, 6 months

negative

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