Intended Use - Dentsply Sirona Primeprint Instructions For Use Manual

3 General information on the device

3.2 Intended use

22
Intended use
3.2
The Dentsply Sirona 3D printer is designed to produce three-
dimensional dental applications from printable viscous materials. It
hereby represents a part of an overall system of Computer Aided
Imaging (data acquisition), Computer Aided Design (modelling of the
application) and Computer Aided Manufacturing (production).
The product only covers the initial manufacturing process. For this
purpose, a light-curing process is used to produce three-dimensional
objects layer-by-layer in a single operation using a projection unit and
printable viscous materials from specific material cartridges.
The subsequent washing and post-exposure treatment that is to be
carried out in the associated post-processing unit after this printing
process is not part of the product.
The data preparation (alignment, positioning, slicing etc.) is part of an
additional CAM software and, like the material used (printable viscous
material), is not part of the product.
CAUTION
Follow the instructions
If the instructions for operating the unit described in this document are
not observed, the intended protection of the user may be impaired.
CAUTION
Federal Law (USA) restricts the sale of this device to or on the order
of a physician, dentist, or licensed practitioner.
3D printing process
CAUTION
The Primeprint 3D printer processes light-curing plastics. These are
not finally polymerized before and after the machining process and
require further post-processing. The materials can lead to injuries if
they are not fully cured. Observe the safety data sheets of the
materials used and use the corresponding and named accessories
(Primeprint PPU) for the post-processing of the printing results.
For cleaning the print results, observe the safety data sheets of the
materials used. These can be obtained from the respective material
manufacturer.
The post-processing of all materials validated in the Dentsply Sirona
Primeprint 3D printer is performed with the Primeprint PPU of the
Dentsply Sirona, REF 6745561 in a validated post-processing process.
Observe the separate operating instructions (REF 67 4 5 2 72).
NOTE
Observe local regulations for the disposal of all operating materials
such as cartridges, gloves, and cleaning supplies associated with use
of the Primeprint 3D printer.
NOTE
Observe the local legal requirements for operating the 3D printer.
Dentsply Sirona
Instructions for Use Primeprint
67 45 1 73 D3691
D3691.201.01.01.02 04.2021