Compatible Devices; Adverse Reactions; Storage Conditions - Dentsply Sirona A175X Instrucciones De Uso

4) COMPATIBLE DEVICES

Gutta-percha points are used in combination with:
• Spreaders and Pluggers. These instruments are used to assure the gutta-percha point is distributed
throughout the entire root canal system.
• Calamus and Gutta-Smart™. They are heating devices that are used to extrude gutta-percha material
®
into the root canal system.
• Gutta-Condensor. Gutta-Condensor is a thermal condenser used to soften and fuse gutta-percha points
together.
• AH Plus Sealer. AH Plus is used to coat root canal walls and remains at the interface between the root
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canal and the gutta-percha.
5) WARNINGS
Single-use products shall not be re-processed nor reused. Reusing these products increases the risk of
cross-contamination and/or breakage.
6) PRECAUTIONS
General:
• Safety and effectiveness of use have not been established in pregnant or breastfeeding women or in
children.
• Inspect the packaging and product before use: if the packaging or the product is damaged, do not use
the product and discard it.
• Products shall be disposed of according to local regulations for the safe disposal of sharp and
contaminated devices.
• Not to be sterilized with heat.
• Do not use disinfecting solutions containing Phenol or any products which are not compatible with gutta-
percha.

7) ADVERSE REACTIONS

In the present technical state, no adverse reaction has been reported so far.

8) STORAGE CONDITIONS

• Keep away from sunlight and heat.
• Maintain under room temperature (< 30°C (86°F)).
• Store in a dry area.
9) STEP-BY-STEP INSTRUCTIONS
The gutta-percha points shall only be used in a clinical or hospital environment, by qualified dental
professionals. The described gutta-percha points are part of a complete system and should only be
used in combination with the corresponding shaping files and paper points. They are identifiable with
their system brand, size name and color code. After shaping and cleaning the root canal, obturation
technique must be set by the professional. This procedure includes the use of gutta-percha points and
sealer. Gutta-percha points shall be selected from the same shaping system and shall correspond to
color code and shaping file size of the last instrument used during canal preparation. The points are to
be disinfected prior to use. A heated instrument can be used to soften the material and ensure perfect
sealing and dimensional adaptation of the root canal. In the use of a heated instrument, follow the IFU of
said instrument. Use an appropriate tool to cut the gutta-percha points, including color coding ring after
the insertion of the gutta-percha point in the root canal. The colored ring shall not remain in the root canal
after insertion.
END-IFU-GUTTA-PERCHA-POINT-CONFORM-FIT-TDS-V01-WEB-EUR-multilingual-2021-05 4/74