SprintRay UMDNS 16-697 EU Denture Base Instruction Manual
- June 10, 2024
- SprintRay
Table of Contents
SprintRay EU Denture Base
Instruction for use
UMDNS 16-697 EU Denture Base
Indication
SprintRay EU Denture Base is a light-curable, polymerizable resin to be
used in conjunction with extraoral light-curing equipment.
SprintRay EU Denture Base is indicated for the fabrication and repair of
removable full and partial dentures and base plates by additive manufacturing.
Contraindication
SprintRay EU Denture Base restorations are contraindicated …
- … if a patient is known to be allergic to any of the ingredients.
- … direct intraoral contact of uncured or partially uncured material.
- … for every application that is not part of the indication (see above).
Requirements
Software:
- RayWare (CAD)
Hardware:
- Pro Desktop 3D (3D Printing)
- Pro Wash / Dry (Cleaning)
- ProCure (Post Curing)
SprintRay, Inc., 3577 North Figueroa St., Los Angeles, CA 90065
Material
SprintRay EU Denture Base consists of functional (meth) acrylic resins, initiators, dyes and stabilisers.
Geometric presetting
Lingual Ridge ≥ 2.5 mm (Maxilla / Mandibula)
Palatal/Lingual ≥ 3.0 mm (Maxilla) / ≥ 2.5 (Mandibula)
Facial/Buccal ≥ 2.5 mm (Maxilla / Mandibula)
Material parameters
Radiation penetration depth controllable by exposure time
≥ 50 μm (4 mils)
≥ 100 μm (5 mils)
Manufacturing process (fi g. 1-10)
UMDNS 16-697
1. Prepare data (RayWare).
2. Choose process parameters (build style, etc.).
3. Transfer prepared data to 3D printing device.
4. Prepare 3D printing – shake bottle.
5. Fill resin tank of 3D printing device.| 6. Build the parts.
7. Clean parts (ProWash / Dry): 5 min. / 5 min.
8. Dry parts (ProWash / Dry): 3 min.
9. Post curing (ProCure): 5 min. / 60 °C.
10. Finish parts.
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Bonding of denture teeth
If using printed denture teeth – see additional IFU SprintRay EU Temporary Crown & Tooth for details. In order to realize the optimal bonding of artifi cial teeth to the dental object, it can be necessary to roughen the surface of the denture and to use an appropriate adhesive. The suitability of a bonding agent or adhesive must be approved prior use. Recommended bonding agent is VITA VIONIC® BOND. The commonly used techniques and dental work steps must be carefully considered when manufacturing the dentures. Please follow the instructions and indications of the corresponding suppliers.
Notice
Please follow the instructions provided by the software manufacturer in terms
of parameter settings and design recommendations. Please follow the
instructions provided by the hardware manufacturer in terms of parameter
settings/printing & post curing recommendations. To avoid detrimental effects
on material quality do not expose the liquid material to irradiation under any
circumstances. Deviations from the described manufacturing processes or
storing conditions may lead to different mechanical and optical properties of
the material. Ensure personal protective gear during processing.
Caution: Polymerized resins are chemically resistant – avoid stains on
clothing! Avoid any contact with skin and eyes! In case of accidental contact,
rinse with adequate running water, consult a doctor if necessary. The lot
number and the best before date are indicated on each packaging. In case of
claims please always indicate the lot number of the product. Do not use the
product after expiry of the best before date. Dispose of contents/container
according to offi cial regulations.
Hazard statements
Causes skin irritation. May cause an allergic skin reaction.
Causes serious eye irritation. May cause respiratory irritation.
- These data come from measurements of a representative sample that was determined as part of our quality assurance.
** According to internal design and requirements specifi cations
Physical properties*
SprintRay EU Denture Base
- Shore hardness D/(ISO 7619-1):> 80**
- Flexural strength /MPa (ISO 20795-1): ≥ 65
- Bending module/MPa (ISO 20795-1): ≥ 2000
- Water absorption/µg/mm3 (ISO 20795-1): < 32
- Solubility/ µg/mm3 (ISO 20795-1): < 1,6
Ordering information
SprintRay EU Denture Base
1 kg: λ≤ 405 nm
orange-pink/REF: SRE-1001302
light-pink/REF: SRE-1001303
deep-pink/REF: SRE-1001304
| This side up.
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| Temperature limit
| CE mark
| Warning
| Do not use if package is damaged.
| Consult instructions for use.
| Keep away from sunlight.
Rx only
QTY: 1EA
| Medical Device
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| Use by date
| Catalogue number
| Lot number
| Date of manufacture
Manufacturer:
pro3dure medical GmbH
Am Burgberg 13 · 58642 Iserlohn, Germany
Phone: +49 (0)2374 920050-0 · Fax +49 (0)2374 920050-50
[email protected] ·
www.pro3dure.com · Made in Germany
Distributor:
SprintRay Europe GmbH
Brunnenweg 11 · 64331 Weiterstadt · Germany
Rev. 2_47/21