Pilot²
Doc. No. 610 2221 v07
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(*applicable with the ultrasonic extension module)
Description of the symbols used.
Prescription Use Only
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
No standard; designated by FDA per 21 CFR 801.109(b)(1)
Temperature Limit
I
ndicates the temperature limits to which the medical device can be safely exposed.
for storage (on package) or use (on device)
ISO 15223-1:2016 / Ref. 5.3.7 (the values in this listing are examples)
1.2.
Intended use
The EndoPilot² systems are dental devices, which combine in a single control unit an endo
motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex
locator which assists the operator to locate the file tip in the root canal and an ultrasonic-
hand-piece for root-canal cleaning and preparation.
The EndoPilot² systems are intended solely for use by trained dental professionals in pro-
fessional health care facilities for patients which needs root-canal-treatment.
1.3.
Device Description
The EndoPilot²
is a device that combines
the
functions:
1.3.1. Apex locator
The apex locator determines the file position in the root canal. This length determination can
either be performed manually (without a motor) by using the file clamp, or during preparation
using the contra-angle (integrated length determination with a motor).
1.3.2. Motor
Mechanical root canal preparation in combination with US registered Endo-File systems,
optional with integrated length determination. The file manufacturer’s current file-parameters
has been integrated in the file database of the device.
1.3.3. DownPack hand-piece with heating tip
Vertical thermoplastic condensation of gutta-percha in the root canal and the cutting off of
gutta-percha pins.
1.3.4. BackFill gun
Final thermoplastic filling of root canals with gutta-percha.
1.3.5. Ultrasonic handpiece*
*The Ultrasonic module has been developed to extend the EndoPilot². It supplements the
device concept with the ultrasonic function for the execution of professional endodontic
treatments in combination with US registered Endo-tools from Satelec Acteon.
