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Evaluation of the clinical effectiveness and safety of the COLOURANT medical device

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Evaluation of the clinical effectiveness and safety of the COLOURANT medical device

Please be informed that your data obtained as a result of previous contacts with ARKONA Laboratorium Farmakologii Stomatologicznej Grzegorz Kalbarczyk (hereinafter referred to as ARKONA) is stored in the ARKONA Contractor Database, which is the administrator of your personal data. Details regarding ARKONA's personal data protection policy are available at https://arkonadent.com/wp-content/uploads/2020/10/arkonadent.com-polityka-prywatnosci.pdf. If you would like to obtain detailed information about the rules and purposes of ARKONA's processing of your personal data, please contact us at the following e-mail address: polityka.prywatnosci@arkonadent.com or at the postal address Nasutów 99C, 21-025 Niemce, Poland.

Doctor's personal details, professional licence number

Please provide your first name, surname and professional licence number. Please be aware that your personal data will not be collected, processed or disseminated without your knowledge and consent. It will only be used to confirm that the survey has been completed by an authorised person.

Address of the dental clinic/ practice

Medical Representative's initials

If applicable
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Evaluation of the clinical effectiveness and safety of the COLOURANT medical device

Since when have you been using the COLOURANT medical device ?

Select one answer

How often do you use COLOURANT in your practice?

Select one answer

Which COLOURANT shades have you used in your practice?

Select one or more answers

Do you consider that the above-mentioned number of shades of the COLOURANT composite is:

Select one answer

Please indicate which shades are missing*

How would you assess the volume (1 g) of material in the COLOURANT package?

Select one answer

For which clinical indications do you use the COLOURANT medical device?

Please tick the indications for which you have used the medical device

In what other indications do you use COLOURANT?*

Have you ever used the COLOURANT medical device on:

Select one answer in each line

How do you assess the clinical effectiveness of the COLOURANT product in relation to the clinical indications listed in the medical device Instructions for Use?

1 – very low, 5– very high

What other indications?*

Please provide your indications and evaluation on a scale of 1-5.

How do you use the COLOURANT?

Select one or more answers

How would you assess the following functional characteristics and features of the COLOURANT product?

(1 – very low 5 – very high)

How would you assess the information on the COLOURANT label or in the instructions for use (indications, method of use, contraindications, side effects, warnings, etc.), i.e. is it complete, sufficient and understandable?

The answer NO should be justified by explaining what information is missing or unclear.

What information is missing or unclear?*

During the last 3 years of your professional practice, has the COLOURANT medical device ever:

Select one answer in each line

What kind of allergic reaction did COLOURANT cause?

Have you ever observed any adverse reactions after using COLOURANT?

The answer YES must be explained. What adverse reactions have been observed?

What adverse reactions have been observed?*

Do you consider COLOURANT to be safe for the clinical indications described in the instructions for use?

The answer NO should be explained.

Why not?*

What factors do you usually consider or would consider when deciding to purchase this type of material?

Select one answer

Do you have any comments, suggestions, ideas or concerns regarding the COLOURANT medical device that would help us improve our product?

Where do you usually obtain information about ARKONA products?

Select one or more answers
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Dziękujemy za poświęcony czas i udzielone odpowiedzi.