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7)
DISINFECTION, CLEANING AND STERILIZATION
Reprocessing procedure for dental instruments and implantable radicular devices
Foreword
For hygiene and sanitary safety purposes, all instruments not marked "sterile" must be cleaned, disinfected
and sterilized before each usage to prevent any contamination. This concerns the first use as well as the
subsequent ones.
Area of application
Disinfection and sterilisation before first usage and reprocessing procedures concerning:
A1. Instruments
Cutting instruments, (hand and engine driven) such as:
Endodontic instruments (files, broaches, reamers, enlargers, endodontic burs, ultrasonic inserts);
Rotary cutting instruments (Diamond burs, tungsten carbide burs, stainless steel drills, carbon steel
burs).
Root canal filling instruments (Pluggers, spreaders, compactors).
Supports, kits and instrument organisers.
Hand instruments and clamps.
A2. Implantable devices
Dentinal and radicular posts made of steel, titanium and glass fibers.
Supports, kits and organiser systems for posts.
A3. Contra angle
B. Filling material: Only chemical disinfection (no sterilisation)
Gutta percha, Thermafil obturation devices.
Exclusion
Equipment such as Motors, Apex locators and other devices with reprocessing procedures included in
the individual Direction for Use.
MTA, Glyde, TopSeal.
General recommendation
Use only a disinfecting solution which is approved for its efficacy (VAH/DGHM-listing, CE marking,
FDA approval) and in accordance with the DFU of the disinfecting solution manufacturer. For all metal
instruments, it is recommended to use anticorrosion disinfecting and cleaning agents.
For your own safety, please wear personal protective equipment (gloves, glasses, mask).
The user is responsible for the sterility of the product for the first cycle and each further usage as well
as for the usage of damaged or dirty instruments where applicable after sterility.
Limitations and restrictions on reprocessing:
The individual DFU indicates if the useful life of a device might be reduced by the number of
reprocessing cycles. Furthermore, the appearance of defects such as cracks, deformations (bent,
twisted), corrosion, loss of colour coding or marking, are indications that the devices are not able to fulfil
the intended use with the required safety level.
Single use marked instruments are not approved for re-use.
The water quality has to be convenient to the local regulations especially for the last rinsing step or with
a washer-disinfector.
Tungsten carbide burs, plastic supports, hand instruments and NiTi instruments are degraded by
Hydrogen Peroxide (H
NiTi Instruments are degraded if immerged more than 5 minutes in a solution of NaOCl at more than
5%.
Instruments made of aluminium are degraded in presence of caustic soda solutions with mercury salt.
Do not use acid (pH < 6) or alkaline (pH > 8) solutions.
The washer-disinfector is not recommended for instruments made of aluminium, tungsten carbide or
carbon steel.
DFU Profile F19 03 10.X/ 11 / 1998 updated 04/2009
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DENTSPLY MAILLEFER
1338 Ballaigues
Switzerland
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