Frequently Asked Questions
Q: How safe and compliant are your biocompatible materials?
A: Keystone Industries is a medical device and pharmaceutical manufacturer and strives to be in compliance with global industry standards. All medical devices undergo rigorous testing for safety and effectiveness per ISO 10993 and product-specific standards.
Q: How long is the shelf life of KeyPrint Resins?
A: KeyPrint® materials are tested for extended shelf life of at least 3 years.
Q: How can I buy accessories for my 3d printing process?
A: Keystone industries has introduced a 3d printing starter kit for those looking for robust tools to use in their workflow.
Q: Where is KeyPrint manufactured?
A: Keyprint is manufactured in New Jersey, USA.
Q: Where is Keyprint warehoused?
A: Keystone Industries warehouses KeyPrint in the USA and EU in Keystone warehouses, together with stock maintained by a wide distribution network around the world.
Q: Does Keystone Industries have technical support for KeyPrint users?
Q: What is the pricing for KeyPrint resins?
A: Keystone Industries offers premium KeyPrint resins at or below competitor prices. There are discounts available for volume users.
Q: What printers will KeyPrint work on?
A: KeyPrint® resins are designed to work in DLP printers with wavelengths from 385-405 nm. Keystone requires the validation of the workflow in order to achieve optimal results. Click here for a list of validated printers and their settings. Keystone continues to profile and validate printers to ensure that KeyPrint resins work reliably in multiple open source printers.
Q: Does KeyPrint work in SLA printers?
A: No. KeyPrint resins are designed to work in DLP printers with wavelengths from 385-405 nm.
Q: Where do I find the settings for my printer?
A: Click here for a list of validated printers and their settings. Keystone continues to profile and validate printers to ensure that KeyPrint resins work reliably in multiple open source printers. If your printer is not listed, contact us to validate.
Q: Which cure boxes and post-cure processes should be used?
A: The post-cure process is well established in the IFU (Instructions for Use) accompanied with the KeyPrint product. You can also find this information on each product’s page on the KeyPrint website.
The user should only use Keystone validated post-cure boxes associated with validated settings for optimal results. Keystone does not guarantee a safe and effective medical device if the directions are not followed.
KeyPrint resins optimally cure in a broad spectrum post-cure box with wavelengths between 280-400nm
Q: What design parameters and design software should I use?
Q: What polishing protocol should I use for the medical devices?
Q: Are KeyModel and KeyOrthoModel the same?
A: Even though both resins deliver a highly accurate model and similar physical properties, KeyOrthoModel can be printed at twice the speed as KeyModel printed at the same layer height. KeyModel can print at 50 and 100 microns for highly accurate modeling, where KeyOrthoModel is optimal for thermoforming and cases where 100 or 200 micron layer accuracy is sufficient.
Q: Is KeyGuide Autoclavable?
A: Yes. Keystone Industries has validated the sterilization protocol of KeyGuide for safety and effectiveness via steam sterilization. The parameters can be found here.
KeySplint Soft and KeySplint Soft Clear for Carbon Printers
Q: What is the difference between KeySplint Soft and KeySplint Soft Clear for Carbon Printers?
A: KSS is a light violet translucent 3D printing resin designed for open source DLP printers and is compatible with most DLP printers with wavelengths between 385-405nm. KSSCCP is a clear/transparent 3D printing resin optimized for the Carbon M-Series printers (385nm). The physical properties of both shades are equivalent, and they are both biocompatible medical devices cleared for sale in the USA (FDA 510k cleared), EU, Canada and Australia.
Q: Where is KeySplint Soft and KeySplint Soft Clear for Carbon available for purchase and use?
A: KeySplint Soft and KeySplint Soft Clear for Carbon are cleared for sale in the EU (Class IIa), Canada (Class II), Australia and the USA (FDA 510k cleared).
Q: What are the wear expectations for KeySplint Soft and KeySplint Soft Clear for Carbon Printers?
A: Based on its unique chemistries, it is expected that KeySplint Soft devices will wear as long, if not longer, than devices made from traditional methods like hand-created acrylic and thermoformed products. Please see the Independent Wear Study of KeySplint Soft and KeySplint Soft Clear for more information.
Q: What design parameters and design software should I use for KeySplint Soft and KeySplint Soft Clear for Carbon Printers?
A: KeyPrint® is an open source line of 3D printing resins designed to be used with the design software chosen by the end-user, for example 3Shape, Exocad, Dentalwings, Blueskybio, etc. Design parameters are left to the dental technician’s discretion based on the dental professional’s prescription.
That said, Keystone has worked closely with 3Shape to create .dme settings for optimized design parameters in the Splint Studio software to be used with Carbon and Asiga printers (more to come). Please look for these settings in the Splint Studio software in late March or early April 2020.
Q: What is the best way to nest KeySplint Soft devices?
A: Nesting parts optimally depends on the workflow. For KeySplint Soft, Keystone recommends to angle the part between 25-40 degrees and with supports for enhanced accuracy. For KeySplint Soft Clear for Carbon Printers, Keystone recommends a 40 degree tilt with the anterior rotated away from the platform with the intaglio surface facing the platform.
Q: What post-curing units and processes should I be using with KeySplint Soft and KeySplint Soft Clear for Carbon?
A: The post-cure process is well established in the IFU (Instructions for Use) accompanied with the KeyPrint product. You can find validated post-cure units here. If your post cure box is not on the list, please contact us for further details.
The user should only use Keystone validated post-cure boxes associated with validated settings for optimal results. Keystone does not guarantee a safe and effective medical device if the directions are not followed. KeyPrint resins optimally cure in a broad spectrum post-cure box with wavelengths between 280-400nm.
Q: What polishing protocol should I use for the medical devices?
Q: What is the difference between the indications for use of KeySplint Soft inside and outside of the United States?
US Indications: KeyPrint KeySplint Soft™ is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, snoring appliances, splints and repositioners.
EU/Canada/Australia Indications: KeyPrint KeySplint Soft™ is indicated for the fabrication of orthodontic and dental appliances such as bite planes, mouthguards, nightguards, snoring appliances, splints and repositioners.
Q: KeySplint Soft and KeySplint Soft Clear for Carbon Printers seem rigid, how is this called a soft material?
A: The unique characteristic of KeySplint Soft and KeySplint Soft Clear is that in room temperature the medical device is more rigid, but when in the body it becomes more flexible for patient comfort.
Q: Can I use KeySplint Soft like a boil-and-bite to try to reform the device?
A: Although the material becomes flexible in body temperature/ warm water, it is not a boil and bite product. The medical device becomes flexible in body temperature and should not be exposed to higher temperature than 45°C due to the increased risk of warping the accuracy of the device. Brief steam cleaning should not cause warping.
Q: How do KeySplint Soft devices compare to traditional splints and other 3D splints.
A: KeySplint Soft and KeySplint Soft Clear are unique 3D dental splint materials that yield a flexible yet tough device, without brittleness. Traditional techniques like thermoforming and PMMA discs are less efficient and become brittle over time.
The Independent Study on the wear of KeySplint Soft and KeySplint Soft Clear devices concluded that equal, if not longer, wear time can be expected when compared to traditional fabrication methods and materials due to the unique properties of KeySplint Soft and KeySplint Soft Clear.
Q: Where can I purchase KeySplint Soft and KeySplint Soft Clear for Carbon Printers?
A: KeySplint Soft can be purchased from several dealers, please check with Keystone’s customer service team for an updated list of dental dealers carrying KeyPrint resins. KeySplint Soft Clear is exclusively available for the Carbon M-series printers and exclusively sold through Henry Schein/Zahn.
Q: If I wanted to make post-printing adjustments by adding traditional acrylic to the KeySplint Soft device, will it bond well?
A: KeySplint Soft is based on methacrylate chemistries and, therefore, traditional acrylics will bind well to the surface of a KeySplint Soft device.
Q: I have printed KeySplint Soft Clear and recognize a slight yellow appearance in the printed part, can this be an issue with the resin?
- Remember to agitate the material in the bottle or the vat before usage. This will ensure consistent dispersion of the pigments and agents that prevent yellowing throughout the resin to achieve consistent color.
- Different lighting conditions and light spectrums will impact the way the human eye perceives the color of the device. If you are concerned, please try looking at the device under several different lighting conditions.
- If the part is subject to a high degree of heat during/after the post cure (>120F), such conditions can cause the chemistries to yield a slight yellowish hue – please ensure that you are following the appropriate settings provided by Keystone Industries and limit heat exposure during the post-cure phase. You also may want to check and ensure your post-cure unit is performing within specification.
- If other color deficiencies are experienced (not from normal patient wear), please call us for additional support.
Q: My KeySplint Soft device looked yellow/green on day 0, but cleared up after a couple days. Why does this happen?
A: The difference between the day 0 and day 2 splint is a photo-bleaching phenomenon inherent in certain UV-cured products and most obvious in “clear” products. The post-cure process will “excite” certain materials for a short duration, and the molecules relax, the discoloration subsides. In summary, if you see this phenomenon, the device should become more clear within 12-24 hours after post cure process is finished. If other color deficiencies are experienced (not from normal patient wear), please call us for support.
Q: What can KeySplint Hard do that KeySplint Soft can't?
A: KeySplint Hard is indicated for devices that require extreme rigidity, such as retianers. It is also useful for NTI’s and other anterior bite devices.
Q: Is KeySplint Hard regulatory compliant?
A: KeySplint Hard is globally compliant with international standards, including FDA 510k-clearance.
Q: What advantages do KeySplint Hard's rigidity give?
A: Rigid materials allow for finer details and thinner segments for a more comfortable, better fitting device. It also allows devices to completely immobilize teeth, and stands up to severe bruxism.
Q: How does KeySplint Hard compare to other rigid splints?
A: KeySplint Hard is less brittle, and a bit more flexible than other leading hard splints. It is also much more abrasion-resistant and better wear expectancy than other rigid splints.