Kulzer Dima Instructions For Use

Print Denture Base
Instructions for use
1. Introduction
2. Intended use
3. Special manufacturing requirements
4. Contraindications
5. Hazards and precautions
6. Storage conditions, expiry date and transport
7. Procedure to print denture base
8. Cleaning
9. Procedures to fabricate a denture using printed denture base
10. post-curing
11. Finishing
12. Repair of denture and baseplates
13. Plastic and packaging waste
14. Instructions for cleaning and disinfecting
15. Delivery units
66077152 R 6/18
Instructions for Use – dima Print Denture Base
1. Introduction
The following instructions for use are for dental technicians, dentists and oral surgeons who use dima Print Denture Base for
final dentures and partials and is intended exclusively for professional dental work. This instruction for use also provides infor-
mation about safety and environmental aspects. A safety data sheet is available on www.kulzerUS.com/downloads. In case more
information is needed regarding the processing of dima Print Denture Base material, contact Kulzer Technical Service at 800-
431-1785. Also see information at the end of this document. dima Print Denture Base material is a light-curable resin indicated
for manufacturing and repairing of 3D printing full and partial temporary removable dentures and baseplates. dima Print Denture
Base material is a Class II medical device material. dima Print Denture Base material shall be used in combination with cara
Print 4.0.
2. Intended use
dima Print Denture Base is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and
baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins. Fabrication of dental
prosthetics with dima Print Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes
the following components: digital denture base files, based on a digital scan of an impression, digital light projection printer
(cara Print 4.0) and curing light equipment (HiLite Power 3D).
3. Special manufacturing requirements
3.1 Digital denture file;
a. STL format file
b. Digital design
c. File size: less than 100mb (each file)
66075564 Dima Denture Base IFU EngOnly_0618-Final.indd 1
Distributed by:
Kulzer, LLC
4315 South Lafayette Blvd.
South Bend, IN 46614
www.KulzerUS.com
Caution: Federal law restricts this device to sale
by or on the order of a dental professional.
3.2. Digital light projection printer – cara Print 4.0
3.2.1 Hardware
a. Polymerization technology: Digital light projection (HD DLP @ 405 nm)
b. Building area: 103 x 58 x 130 mm
c. Resolution (X & Y-axes): 53.6 μm
d. L ayer thickness (Z-axis resolution): 30 – 150 μm (varies by indication & speed vs. resolution needs)
e. A verage build speed: 50 mm/hour (@ 50 μm); Min./Max. build speed: 15 – 120 mm/hour
f. Average duration of 1 print cycle: < 1 hour
g. Connectivity: WiFi, Ethernet or USB
h. Input format: Open STL
I. CAD software compatibility: All CAD programs using open STL
j. CAM software: cara Print 4.0 CAM, included with purchase
k. Printer dimensions: 267 x 420 x 593 mm
l. Printer weight: 21 kg
3.2.2 Features of operation software
Recommended software: cara Print 4.0 CAM performed by the cara printer manufactured by Kulzer
a. STL file import
b. Place and rotate file on the build plate for proper positioning
c. Add supports via manual function or auto function
3.2.3 Printing parameters
a. Layer thickness: 50 micron or 100 micron
b. Optimal orientation: 90 degree tilted orientation
c. Support point size: 0.4 – 1.0 mm
d. Support density: 0.7 – 1.5
3.2.4 Environmental conditions
a. Temperature: 18 – 30°C
b. Relative humidity: 30 – 90%
3.2.5 Cleaning kit inclusive of a rinse bath, flush cutter, paper towel, squeeze bottle for isopropyl alcohol and scraper
3.2.6 Recommended printer
a. cara Print 4.0
3.3. Recommended curing light equipment (post curing units)
3.3.1 UV curing light equipment – post processing [HiLite Power 3D]
a. Main voltage: 100/115/230 V (via voltage selector switch)
b. Rated frequency: 50 – 60 Hz
c. Flash lamp power: 300 W
d. Fuse protection: T6,3A
e. Power consumption: 360 VA
f. Dimensions (H x D x W): app. 225 x 330 x 220 mm
g. Weight: app. 9.5 kg
h. Protection rating: Class I
I. Power-on time: 80%
j. Curing time: 20 mins.
3.3.2 Accessories
a. USP grade glycerin
b. Transparent glass container and plate
4. Contraindications
dima Print Denture Base must not be used for any other purpose than dental removable or fixed dentures. Any deviation from this
instruction for use may have a negative effect on the chemical and physical quality of dima Print Denture Base.
Caution: In case of an allergic reaction, please contact a physician. dima Print Denture Base contains Acrylic Oligomer and
Acrylic Monomer that may cause allergic reactions in predisposed persons.
5. Hazards & precautions
Inhalation:
Avoid inhalation. High vapor concentration can cause headache and irritation of respiratory system. In case of exposure to a
high concentration of vapor or mist, remove person to fresh air. Give oxygen or artificial respiration as required.
6/29/2018 11:50:11 AM