Storage Conditions - Dentsply Sirona Thermafil Gebrauchsanweisung

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Dissatisfaction of the user and delay in treatment / Patient discomfort.
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Retreatment (initial infection never healed).
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Serious infection / Serious health consequences for the patient (e.g. biological hazards
such as infection, toxic or allergic reaction for the patient) have never been reported and
are very unlikely but cannot be totally excluded.
8 PRECAUTIONS
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Safety and effectiveness of use have not been established in pregnant or breastfeeding
women or in children.
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Inspect the packaging and product before use: if the packaging or the product is damaged,
do not use the product and discard it.
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Use a rubber dam system during the endodontic procedure.
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For your own safety, wear personal protective equipment (gloves, glasses, mask).
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Products shall be disposed of according to local regulations for the safe disposal of sharp
and contaminated devices.
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Thermafil® obturators shall not to be sterilized.
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Do not use disinfecting solutions containing Phenol or any products which are not
compatible with the treated filling material.
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Select the Thermafil® obturators according to the appropriate size verifier that fits the
shaped canal passively. Thermafil® obturators and/or hand files should not be used as
size verifiers.
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Do not remove gutta-percha from the apical section of the obturator prior to filling the root
canal space. Removing the gutta-percha may damage the obturator.
9 ADVERSE REACTIONS / UNDESIRABLE SIDE-EFFECTS
Following undesirable side effects may occur:
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Patients with latex sensitivity may experience allergic reactions to Thermafil® obturators;
due to potential presence of dry natural rubber.
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Temporary post-operative discomfort could arise generally as a result of receiving a root
canal treatment.
10

STORAGE CONDITIONS

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Keep away from sunlight and heat.
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Maintain under room temperature (≤ 30°C (86°F)).
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Store in a dry area.
11 STEP-BY-STEP INSTRUCTIONS
The obturators shall only be used in a clinical or hospital environment, by qualified dental
professionals.
1) After shaping and cleaning the root canal, obturation technique must be set by the
professional.
END-IFU-THERMAFIL-OBTURATOR-MSA-V00-WEB-EUR-Multilingual-2022-08 4/161