Dentsply Sirona A175X Instrucciones De Uso página 5

10)DISINFECTION
Immerse the gutta-percha points in 5.25% NaOCl for 1 to 5 minutes at ambient temperature. Remove all
the bubbles from the surface of the gutta-percha point. Gently wipe the gutta-percha point with a sterile
gauze moistened with 70% isopropyl alcohol. Let the gutta-percha points air dry.
Do not use disinfecting solutions containing Phenol or any products which are not compatible with gutta-
percha.
11)SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
Information is available in the European database on medical devices (EUDAMED), where it is linked to
the Basic UDI-DI.
https://ec.europa.eu/tools/eudamed
The Basic UDI number is: TBD
12)LOT NUMBER AND EXPIRATION DATE
Do not use after expiration date.
13)SERIOUS INCIDENT REPORTING
Any serious incident in relation to the product should be reported to the manufacturer and competent
authority according to regulations.
Disclaimer:
Users are solely responsible for any deviation from these instructions, and/or the use of alternative
methods for processing. Dentsply Sirona accepts no liability for damage, injury, or any legal responsibility
incurred directly or indirectly by the user due to a deviation from the instructions for use set forth below.
The user shall observe safe and lawful practices including, but not limited to, those set forth in this
document.
Authorised Representative
DENTSPLY DeTrey GmbH
De-Trey-Straße 1
D-78467 Konstanz
Germany
Made in USA
END-IFU-GUTTA-PERCHA-POINT-CONFORM-FIT-TDS-V01-WEB-EUR-multilingual-2021-05
Manufacturer
DENTSPLY Tulsa Dental Specialties
608 Rolling Hills Drive
2797
Johnson City, TN 37604, USA
www.dentsplysirona.com/ifu
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