Dental LT Comfort Resin and Dental LT Clear Resin V2 Are FDA-Cleared for 3D Printing Mouthguards

Man holding up a clear occlusal splint in front of his face

When it comes to 3D printing mouthguards, dental professionals now have two FDA-cleared options from Formlabs Dental: Dental LT Comfort Resin and Dental LT Clear Resin V2. Both resins have received a 510(k) medical device clearance for prescription mouthguards from the FDA, meaning dental labs, dental practices, and orthodontic practices can directly print mouthguards. 

Both Dental LT Comfort Resin and Dental LT Clear Resin V2 are biocompatible materials and can be used to print appliances for long-term use that are comfortable for the patient and polish to high optical transparency. These groundbreaking materials are a part of Formlabs’ comprehensive Dental Resin Library, which makes it easy for dentists, lab technicians, and service providers to 3D print an ever-expanding variety of appliances with accuracy.

Dental LT Comfort Resin
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Dental LT Comfort Resin: Announcing Formlabs Most Flexible Dental Material

Watch this webinar to learn more about Dental LT Comfort Resin, our new flexible, and durable material, which is optimal for comfortable long-term splints and occlusal guards.

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Biocompatible Resins for 3D Printing Occlusal Splints

Mouthguards, occlusal splints, and nightguards require a smooth surface finish for patient comfort while maximizing cleanliness and minimizing chances for bacterial growth. Both Dental LT Comfort Resin and Dental LT Clear Resin V2 print with excellent optical clarity, and polish to a smooth finish, meaning less labor involved for a superior result.

Dental LT Comfort Resin

Two clear occlusal splints on metal tray. One is on a model.

Dental LT Comfort Resin becomes softer intraorally for increased patient comfort.

Traditionally fabricated splints, whether 3D printed or milled, are often stiffer and more prone to cracking. Dental LT Comfort Resin was designed to combine the long-lasting strength, flexibility, and impact resistance of advanced plastics to withstand biting, grinding, and use. Appliances printed with Dental LT Comfort Resin are comfortable and easy to wear. They also become softer intraorally, increasing comfort for patients once placed intraorally.

"I have been using Key Splint Soft for years, but when I had the opportunity to beta-test the new dental splint material called Dental LT Comfort from Formlabs Dental, I was amazed. The material's pre-polished appearance and exceptional translucency right after printing significantly reduced post-processing time. Furthermore, I was impressed by its fracture resistance and flexibility, which ensure optimal comfort, making it the perfect choice for dental splints."

Stephan Kreimer, Director, Kreimer Dentallabor GmbH & Co. KG

Dental LT Clear Resin V2

Blue gloved hand holding a clear occlusal splint

Dental LT Clear Resin V2 polishes to high optical transparency and resists discoloration.

Dental LT Clear Resin V2 is the second generation of our long-term, biocompatible material for rigid occlusal splints, mouthguards, and night guards. Dental LT Clear Resin V2 is highly durable and resistant to fracture. This clear material polishes to high optical transparency and resists discoloration over time.

Manufactured at Our FDA-Registered Facility

Formlabs manufactures our Biomed and Medical Device Resins, including Dental LT Comfort Resin and Dental LT Clear Resin V2, at Spectra, our FDA-registered facility in Ohio. These materials are designed and manufactured within our robust Quality Management System that is ISO 13485 and EU MDR certified.

A dedicated team of operators and quality assurance professionals make Formlabs resins inside a certified ISO Class 8 clean room. Formlabs’ Regulatory Affairs and Quality Assurance (RAQA) team oversees every aspect of the development and production of our resins. All of our Medical Device Resins are appropriately registered with the FDA and CE Marked according to the EU MDR. Documents are available from our RAQA team upon request.

Which to Use? Dental LT Comfort Resin vs. Dental LT Clear V2 Resin

Dental LT Comfort Resin and Dental LT Clear Resin V2 have similar surface hardness values at room temperature. When 3D printed into occlusal splits and properly post-processed, the two materials exhibit some key differences that should be considered based on the design of the appliance, and patient characteristics and demands.

Three clear occlusal splints. One on a model and one still with 3D printed supports attached.

High polishability and clarity make post-processing 3D printed occlusal splints fast and easy.

Behavior in the Intraoral Environment

Appliances printed with Dental LT Comfort Resin will become less rigid and more flexible in environments that are 37 °C or higher. This change in the material adds resilience to the part and can provide a more comfortable fit for patients. To test this for yourself, submerge an occlusal splint printed with Dental LT Comfort Resin in a hot cup of water for 15-30 seconds. Take it out and you'll see that the material becomes more flexible. 

By comparison, occlusal splints printed with Dental LT Clear Resin V2 will remain more rigid than Dental LT Comfort Resin in warm environments, including intraoral ones. 

Our materials are rigorously tested. For strength, we typically test tensile strength, flexural strength, and notched/unnotched IZOD for impact strength. Dental LT Clear Resin V2 and Dental LT Comfort Resin are designed to perform differently across these types of strengths, meaning patients will have different experiences and oral sensations with splints printed in each material.

Dental LT Comfort ResinDental LT Clear Resin V2
Hardness Shore D75D78D
Ultimate Tensile Strength29 MPa52 MPa
Flexural Strength21 MPa84 MPa
Flexural Modulus643 MPa2300 MPa
Impact Strength 1340 J/m449 J/m
Elongation at Break33%12%

Specifically, Dental LT Clear Resin V2 is designed for use as a rigid occlusal splint, has higher tensile and flexural strength, meaning it is harder to bend and more resistant to deformation. In cases where a patient is a heavy bruxer, this material is comparable to traditional acrylic splints in terms of rigidity, longevity, and performance

Dental LT Comfort Resin, designed as a flexible splint, has higher impact strength for more durability needed for heavier bruxism cases or for patients that have a lower tolerance to rigid splints.

Indications

Dental LT Comfort Resin and Dental LT Clear Resin V2 can be used with Formlabs stereolithography (SLA) 3D printers for 3D printing the following indications: 

  • Mouthguards
  • Occlusal Splints
  • Nightguards

Step-by-step guides are available for approved dental indications, empowering dental professionals to adopt streamlined workflows for maximum efficiency.

Build platform with 3D printed occlusal splints on it
WHITE PAPER

3D Printing Occlusal Splints with Formlabs SLA 3D Printers

This application guide demonstrates each step for making 3D printed occlusal splints on Formlabs SLA 3D printers.

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Start 3D Printing Mouthguards

With 510(k) clearance from the FDA and robust quality controls for resin manufacturing, dental professionals are empowered to 3D print mouthguards, night guards, and occlusal splints with ease. 3D printing removes barriers to workflows, making it easy and affordable to gain more control over treatment plans, all while matching industry standards for strength, clarity, and patient comfort. 

To test the durability and polishability of our dental materials for yourself, request a free sample below, or talk to a Formlabs Dental expert to find the solution that fits your goals.

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