SprintRay Dental 3D Printing Materials Instruction Manual

: June 10, 2024
: SprintRay

Table of Contents

SprintRay Dental 3D Printing Materials
Product Information
Product Usage Instructions
Indications for Use
Contraindications
Safety instructions
Side effects and precautions Precautions / Protection
General information on handling Delivery
Processing requirements
Luting
Disposal
Material properties and scope of delivery
Label symbols
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

SprintRay Dental 3D Printing Materials

SprintRay-Dental-3D-Printing-Materials-product

Product Information

The SprintRay Crown restoration is a dental product that is used for individualization and veneering of artificial teeth. The product is manufactured by SprintRay Inc. and distributed in the USA. The product can be customized with commercial composite stain materials and veneering materials. The product can be attached to tooth stumps using self-adhesive cements or composite cement with a primer.

Individualization with composite stain : Commercially available composite stain materials can be used for individualization of the post-cured SprintRay Crown restoration. The manufacturer’s instructions for use must be observed.
Individualization with veneering materials: Commercially available composite veneering materials can be used for individualization of the restoration. The manufacturer’s instructions for use must be observed.
Veneer shells : Commercially available light-curing veneering composites can be used to attach the post-cured veneer shells to the metal framework. When designing and preparing the metal framework and processing the veneering material, the instructions for use of the veneering material manufacturer must beobserved.

Product Usage Instructions

For individualization with composite stain, use commercially available composite stain materials (e.g. VITA ENAMIC STAIN, Vita Zahnfabrik, and GC OPTIGLAZE Color, GC) according to the manufacturer’s instructions.
For individualization with veneering materials, use commercially available composite veneering materials (e.g. VITAVM LC, Vita Zahnfabrik, and VITAVM LC flow, Vita Zahnfabrik) according to the manufacturer’s instructions.
For veneer shells, follow these basic work steps:
- Condition the surface of the metal framework.
- Cover the metal framework with opaquer.
- Sandblast the inside of the veneer shell and clean the veneer shell from dust.
- Condition the inner surface of the veneer shell.
- Apply the veneering material to the inside of the veneer shell or the metal framework.
- Position the veneer shell on the metal framework and remove the excess with a brush or an instrument.
- Carry out the polymerization according to the instructions of the veneering material manufacturer.
- Finally, the surface of the veneer shell should be polished or customized with composite stains.
For attachment to tooth stumps, use self-adhesive cements (e.g. RelyX Unicem, 3M Espe) or composite cement with a primer (e.g. Variolink Esthetic DC and Monobond Plus*, Ivoclar Vivadent) according to the instructions for use of the luting agent. It is not required to etch the restoration before attaching.
For high-gloss polishing, use composite polishers commonly used in dental practice according to the instructions for use of the luting agent. Additional exposure to curing lights after attachment will not affect the properties of the finished object.
Dispose of cured, separated material (base plate, support structure) as domestic waste.

SprintRay Crown
Resin for 3D printing of permanent single crowns, inlays, onlays and veneers. SprintRay Crown is used within a dental CAD/CAM workflow and should only be used with compatible 3D printers and post-curing devices. Section 6. below in- cludes a list of requirements for the use of this device.

CAUTION : Federal law restricts this device to sale by or on the order of a dentist. For professional use only – Rx Only. SprintRay Crown is a light- cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers. SprintRay Crown is suitable for restoration of occlusal surfaces. SprintRay Crown is cured externally to the patient by light sources within the 3D printer and the post-curing device de- scribed below.

Indications for Use

SprintRay Crown is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The SprintRay Crown material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.

Contraindications

Known allergy to one or more ingredients. In cases of doubt, the allergyshouldbeclarifiedandruledoutbasedonaspecifictestprior to the application of this product. SprintRay Crown should not be used for purposes other than the production of permanent single crowns, inlays, onlays and veneers. Any deviation from these instructions for use can have negative effects on the chemical and physical quality of objects made from SprintRay Crown.

Safety instructions

SprintRay Crown is produced and tested according to the stringent quality standards. In order to ensure optimum fur-ther processing, please read the information contained in the instructions for use carefully. The improper use of SprintRay Crown and failure to follow information can have a detrimen-tal effect on the quality of objects produced from SprintRay Crown 3D resin. Nitrile gloves, safety goggles and a coat must be worn as a means of protection when handling the resin and the object that has not been post- cured. Conventional medical gloves do not offer any lasting protection against the sensitising effect of methacrylates. If the product comes into contact with the glove, take the glove off and discard it, wash your hands immediately with water and soap and put on a new glove. Consult a physician in the event of an allergic reaction. The safety and care instructions set down in the SprintRay Crown instructions for use and safety data sheet shall apply to the handling of liquid resin and printed objects that have not been post-cured (objects in the “green condition”). A dust mask must be worn too due to potential dust formation while the printed objects are being processed.

Side effects and precautions Precautions / Protection

Protective clothing should be worn when handling un-cured SprintRay Crown. Safety goggles and nitrile gloves must be used. Further information on handling the product can be found in the safety data sheet and also downloaded at www.sprintray. com. However, we cannot completely rule out the possibility of personal reactions to individual components in isola ted cases. In such cases, the respective user should discontinue use of SprintRay Crown. Information on hazards as per MSDS

Causes skin irritation.
May cause an allergic skin reaction.
Causes serious eye irritation.
May cause respiratory irritation.
May damage fertility or the unborn child.

Safety instructions as per MSDS Prevention

Obtain special instructions before use.
Do not handle until all safety precau-tions have been read and understood.
Avoid breathing dust.
Wash thoroughly after handling. Use only outdoors or in a well-ventilated area.
Contaminated work clothing must not be allowed out of the workplace.
Wearprotectivegloves / protective clothing / eyeprotection / faceprotection.

Response

If on skin : Wash with plenty of water and soap.
If inhaled : Remove person to fresh air and keep comfortable for breathing.
If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If exposed or concerned : Get medical advice / attention.
Callapoisoncenter / doctorifyoufeel unwell.
Specifictreatment(seefirstaidinstruction on this label).
If skin irritation occurs: Get medical advice / attention.
Take off contaminated clothing and wash it before reuse.
Wash contaminated clothing before reuse.

Storage

Store in a well-ventilated place. Keep container tightly closed.
Store locked up.

Disposal
Disposeofcontents / containertoafacility in accordance with local and national regulations

Patient precautions
If intolerances or allergic reactions occur when it comes into contact with the patient, discontinue use of the material.

General information on handling Delivery

SprintRay Crown is supplied in seven colours according to the VITA* classical shade system, in lightproof and sealed bottles.

Filling quantity:

SRI-0205040 = SprintRay Crown A1, 500g
SRI-0205041 = SprintRay Crown A2, 500g
SRI-0205042 = SprintRay Crown A3, 500g
SRI-0205043 = SprintRay Crown B1, 500g
SRI-0205044 = SprintRay Crown B3, 500g
SRI-0205045 = SprintRay Crown C2, 500g
SRI-0205046 = SprintRay Crown D3, 500g

Note : The availability of individual product variants may vary from region to region. The latest product information can be found on the SprintRay website.

Storage
SprintRay Crown must be stored in the original sealed bottle, or in the resin tank at room temperature (approx. 22 °C) in adark, dry place. Unused resin in the resin tank has to be stored in the closed printer which protects the resin from light, or in an alternative dark, dry location. It must be ensured that the temperature does not drop below +4 °C and does not exceed +28 °C! The minimum shelf life date printed on the product must be observed.
CAUTION: Expected results cannot be guaranteed if materials which have exceeded their minimum shelf life date are used or if storage instructions are not followed.
The completely cured print objects must be stored at room tem-perature and protected from sources of light.

Processing requirements

Design

Createtheobject(STL-file)usingacommercialCADsoft-ware, which is intended for dental applications.
The design must match the anatomical dimensions of the tooth to be restored.
The ratio of the crown height to the height of the bonding surface of the abutment must not exceed a value of 1.6. When designing, observe the requirements for minimum wallthicknessesforfinishedrestorations.

Crowns, inlays, onlays and veneers

Minimum wall thicknesses anterior teeth 1.0 mm
Minimum wall thicknesses posterior teeth 1.0 mm
Minimal wall thickness, cervical 1.0 mm
Minimal wall thickness, veneer shell 0.5 mm

Nesting & preparation for printing

Import STL file
Manual / Automatic rotation and placement
Optimal orientation: horizontal, occlusal plane facing the build platform
Automatic generation of supports

Printing
SprintRay Crown has been verified and validated in combination with various system components (3D printers, cleaning devices and post-curing devices). We are constantly working on further qualifications. You can find these compatible system components on our website https://sprintray.com/sprintray- open-certified-resin-system/#list Please pay special attention to the build platform and resin tank materials as noted in the compatibility matrix. An example list of compatible 3D additive manufacturing printers and their operation software

Compatible 3D Printers

WARNING : This material is suitable for manufacturing highly reliable dental products only when using approved compatible systems including the material parameters. If unapproved components or material parameters are used, there is a high risk of unreliable and / or unusable products which may endanger the safety of the user.

CAUTION : It is important to follow the instructions for use for selecting the correct material program and maintenance instructions provided by the manufacturer for all system components.

Environmental Conditions
Temperature range between 18 °C and 28 °C

Printing Parameters

Layer thickness : 50 μm
Optimal orientation : horizontal orientation, occlusal plane facing the build platform.

Necessary tools, equipment and materials for post-processing

Stainless steel spatula
Unheated ultrasonic bath
Ethanol solution 96 %
Spray bottle with 96 % ethanol solution
Cutting wheel or side cutters (for support structure removal)
Sandblaster 1.5 bar
Glass bead blasting material 50 μm (e. g. BEGO Perlablast® micro)

Processing

The following instructions contain details of a validated workflow for the 3D printing process with a compatible 3D printer. The ideal working temperature of SprintRay Crown is in the temperature range between 18 °C and 28 °C. Before use, the resin must be homogeneous. Before the first use, the material has to be shaken well about 2 min. When decanting, make sure that the printing resin is exposed to daylight for as short a period of time as possible. Mix the resin in the cartridge / resin tank if a transparent layer is visible on the surface.

CAUTION : The device specifications have been validated using the software, printers, and process parameters specified in this document. Any unauthorized changes to the process equipment, parameters, or software may result in a device that is out of specification and not covered under the FDA clearance. Users shall follow this document in order to use the SprintRay Crown. Users shall also follow the instructions for use documents and all maintenance requirements for the equipment identified in this document

Cleaning and preparation for post-curing
On completion of printing, the print objects are released from the build platform using the spatula. The print object should be cleaned in two steps with ethanol (96 %) using an ultrasonic bath. For additional cleaning devices and methods refer to https://sprintray.com/sprintray-open-certified-resin- system/#list

CAUTION: Never fill ethanol directly into the ultrasonic bath; place it in the recommended container in the ultrasonic bath filled with water. Use an explosion-proof ultrasonic bath

Clean the print object for 3 min in a reusable ethanol solution (96 %) using an unheated ultrasonic bath.
The precleaned object must be cleaned thoroughly for 2 min using a fresh ethanol (96 %) solution with the aid of an unheated ultrasonic bath.
The print object is then removed from the ethanol bath and sprayed with additional ethanol (96 %) in order to fully rinse off any remaining resin residue.
Tip : Resin residues can also be removed using a brush soaked in ethanol (96 %).

CAUTION : The entire cleaning process should not take longer than 5 min as this could otherwise have a detrimental effect on the printed objects (swelling of the object with ethanol). After cleaning, the print object is dried using compressed air under an extraction unit. If there is liquid resin still adhering to the surface of the object, this can be completely removed by spraying again with ethanol (96 %) and re-drying.

Preparation for post-curing
Remove the support structure with the help of a cutting wheel or side cutters. Sandblast the surface of the objects carefully with BEGO Perlablast® micro and at a maximum blasting pressure of 1.5 bar. Check for fit and finish the objects completely. Finishing and countouring can be performed using carbide cutter or diamond grinding stones.

Post-curing process
The final properties of the printed object depend on the post-curing process. Please note the assignment of the light curing device to the 3D printer of the approved system components. The post-curing of the object is done without use of a model, followed by cooling time until object is cool to the touch (3 – 5 minutes). SprintRay Crown has been verified and validated in combination with various system components (3D printers, cleaning devices and post-curing devices). You can find these compatible system components on our website https://sprintray.com/sprintray-open-certified-resin-system/#list An example list of compatible post-curing devices

Post-curing

WARNING : This material is suitable for manufacturing highly reliable dental products only when using approved compatible systems including the material parameters. If unapproved components or material parameters are used, there is a high risk of unreliable and / or unusable products which may endanger the safety of the user.

Note : The times given only apply to regularly maintained equipment that guarantees a corresponding light intensity.

CAUTION : If there is an interruption or failure in the post-curing device cycle, the printed object should not be used until it has cured under a full cycle. Check the post-curing device manual for use for how to properly resolve the post-curing device condition and then repeat the post-curing cycle with the printed objects.

Supplementing of printed objects
Defects (e. g. missing contact points, fractures, etc.) can be supplemented with the resin or with commercially available composite veneering materials.

Blast the areas to be supplemented with aluminum oxide – pressure 1.5 bar and particle size 110 μm.
Put some liquid SprintRay Crown on the object.
Put it under UV-light for a short time.
If more material has to be applied, put additional liquid SprintRay Crown on the last layer and then put it again under UV-light for a short time.
Final curing of the objects is carried out as described in the section “Post-curing process” (see table).

Supplementing with veneering material
The printed objects can be supplemented with commercially available composite veneering materials (e. g. VITAVM LC, Vita Zahnfabrik, and VITAVM LC flow, Vita Zahnfabrik). The manufacturer’s instructions for use must be observed.

CAUTION: The dental object may only be repaired or supplemented outside the patient’s mouth and by a dental professional.

Polish
Polish the surface of the objects with pumice stone and polishing compound. Avoid overheating of the restorations during polishing. Optimal surface quality is achieved by polishing after post-curing.

Tip : Optionally, the surface of the objects can be coated with light- curing glaze (e. g. Vita ENAMIC GLAZE , Vita Zahnfabrik or GC OPTIGLAZE , GC). Pay attention to the manufacturer`s instructions for use.

Individualization (optional)
Instead of polishing the surface, the post-cured objects can also be individualized with composite stains or veneering materials. It may affect the color result.

Individualization with composite stain
Commercially available composite stain materials (e. g. VITA ENAMIC STAIN, Vita Zahnfabrik and GC OPTIGLAZE Color, GC) can be used for individualization of the post-cured SprintRay Crown restoration. The manufacturer’s instructions for use must be observed.

Individualization with veneering materials
Commercially available composite veneering materials (e. g. VITAVM LC, Vita Zahnfabrik and VITAVM LC flow, Vita Zahnfabrik) can be used for individualization of the restoration. The manufacturer’s instructions for use must be observed.

Veneer shells
Commercially available light-curing veneering composites can be used to attach the post-cured veneer shells to the metal framework (e. g. VITAVM LC, VITAVM LC flow, Vita Zahnfabrik). When designing and preparing the metal framework and processing the veneering material, the instructions for use of the veneering material manufacturer must be observed.

Basic work steps

Condition the surface of the metal framework.
Cover the metal framework with opaquer.
Sandblast the inside of the veneer shell and clean the veneer shell from dust.
Inner surface conditioning of the veneer shell. Observe the information of the veneering material manufacturer in section “Individualization of composite frameworks” or “Individualization of artificial teeth”.
Applying the veneering material to the inside of the veneer shell or the metal framework.
Positioning of the veneer shell on the metal framework and remove the excess with a brush or an instrument.
Carry out the polymerization according to the instructions of the veneering material manufacturer.
Finally, the surface of the veneer shell should be polished or customized with composite stains (see section “Polishing” or “Individualization”).

Cleaning in the dental laboratory and dental practice
Fully cured objects made from SprintRay Crown may be cleaned and disinfected. Steam cleaning (e. g., with Triton SLA) is possible. Disinfection in the immersion bath (e. g. ethanol 96 % or MD 520* impression disinfectant, Dürr Dental Co.) is also possible. Follow manufacturer’s instructions

Luting

Cementation on abutments
The definitive restoration can be fixed onto titanium abutments (e. g. BEGO Semados® solid titanium abutments) with Panavia v5 (Kuraray Noritake*). The instructions for use of the luting agent manufacturer must me observed.

Attachment to tooth stump
The finished permanent restorations can be attached using self-adhesive cements (e. g. RelyX Unicem, 3M Espe) or composite cement with a primer (e. g. Variolink Esthetic DC and Monobond Plus*, Ivoclar Vivadent). Observe the instructions for use of the luting agent.

Note for practitioners

Restorations can undergo high-gloss polishing with composite polishers commonly used in dental practice.
Observe the instructions for use of the luting agent. It is not required to etch the restoration before attaching.
Additional exposure to curing lights after attachment will not affect the properties of the finished object.