SprintRay DCO 1275 NightGuard Flex Material Revelation In Smile Protection Instructions
- May 15, 2024
- SprintRay
Table of Contents
SprintRay NightGuard Flex
Instructions for Use
A guide for consistently delivering biocompatible appliances
NightGuard Flex™ was formulated from the ground up to create the fastest, most
comfortable 3D printed occlusal guard in dentistry. This biocompatible
material features high-impact strength and flexure at body temperature; your
patients will love the comfort and longevity. Achieve superior fit and finish
with a guard that is easy to polish and clean. Plus, NightGuard Flex™ is
flavorless, ensuring smooth delivery. Designed to work with SprintRay Cloud
Design and Pro 3D printing systems, NightGuard Flex™ creates efficiencies across
your workflow so you can focus on protecting more smiles. Faster printing
speeds and improved dimensional stability while printing means you save time
and resin by using fewer supports. With NightGuard Flex, ™ SprintRay delivers
on the frictionless occlusal guard workflow– from scan to design, to printing
and placement, protecting more smiles and delighting more patients.
Indications for Use
SprintRay NightGuard Flex is indicated for the fabrication of dental
appliances such mouthguards and nightguards.
Contraindications
SprintRay NightGuard Flex is contraindicated when:
- a patient is known to be allergic to any of the ingredients
- there is direct intraoral contact with resin that is not fully cured
- it is used for any purpose other than its indications for use
Device Description
NightGuard Flex is an alternative to traditional hard occlusal guard material that is intended exclusively for professional dental work.
Printing and Hardware Parameters
These device specifications have been validated using the following
manufacturing products. Any products or processes not specified in this
document are outside of the device specifications.
a. CAD File: CAD file of treatment device in STL file format
i. Minimum thickness 1.0 mm
b. Printer: SprintRay Pro or Pro S DLP 3D printer
i. 55 or 95 micron XY resolution
c. Software: RayWare Desktop or RayWare Cloud
i. STL file import
ii. Manual/automatic orientation
d. Printing Parameters
i. Intaglio surface facing away from build platform
ii. 100 micron layer thickness
iii. Default support structures
e. Wash Device: SprintRay Pro Wash/Dry (recommended) or hand spray & wipe
i. 91% or higher IPA
ii. Standard preprogrammed wash cycle
f. Cure Device: SprintRay ProCure 2 or ProCure
i. Use manufacturer recommended curing times
Warning and Precautions
SprintRay NightGuard Flex is non-toxic in processed, cured form, and is classified as a biocompatible material. In uncured form, NightGuard Flex is classified as a sensitizer. When washing with solvent or grinding the devicedo so in a well-ventilated area with proper protective equipment.
- Skin Contact: May cause skin irritation. If unprocessed resin contacts skin, wash thoroughly with soap and water. May cause an allergic skin reaction. If skin sensitization occurs, stop using. If dermatitis or other symptoms persist, seek medical assistance.
- Inhalation: High vapor concentration may cause headache, irritation of eyes and/or respiratory system. If exposed to a high concentration of vapor or mist, move to fresh air. Use oxygen or artificial respiration as required.
- Eye Contact: Wash the contacted area thoroughly with soap and water.
- Ingestion: Contact your regional poison control center immediately.
Storage
- Material Reuse: The remaining resin in the resin tank can be reused. You may use a filter to ensure the resin is free from any cured particles to avoid print failures. The remaining material in the tank can be poured back into the resin bottle upon filtration. This process can be repeated until the material in the bottle is fully consumed. Please note that in the case of reuse, the resin must be filtered and poured back into the same bottle.
- Store NightGuard Flex at 15-25 °C (60-77 °F) and avoid direct sunlight.
- Keep the bottle closed and/or the tank lid securely attached when not in use.
- Before disposal, completely polymerize .
- Do not use NightGuard Flex after the expiration date printed on the bottle.
Do not use expired resinbiocompatibility and print stability may be compromised if expired photoinitiators do not activate properly.
Fabrication of Device
Designing
The device is designed in STL file format by a dental design service or dental
CAD software using digital anatomical data from the patient. This STL file is
delivered to the clinician for fabrication.
3D Printing
Sign in to RayWare Cloud and select the appliance type; the algorithm will
automatically orient and add supports. Select SprintRay NightGuard Flex
material and use 100-micron layer thickness. Queue the job to your printer.
Shake the resin bottle thoroughly for one minute, then pour into the resin
tank up to at least the min fill line. From the printer touchscreen, navigate
to the printer queue. Start the print job.
Part and Support Removal
After your device has been printed, remove it from the print platform using
the provided Print Removal Tool. Remove all supports using a flush cutter or
round diamond disc. Cut as close as possible to the device to minimize the
smoothening and finishing procedure.
Washing and Drying
Use ≥91% IPA to wash the device using the SprintRay Pro Wash/Dry:
- Standard cleaning cycle
Dry the part completely before post curing.
Post Curing
Use one of the following post-curing equipment from SprintRay to cure the
device and select the preprogrammed profile for NightGuard Flex:
- ProCure 2
- ProCure
Finishing
Use A Scotch-Brite/Fuzzies Wheel with a lab handpiece to smoothen the surface.
Polishing and Disinfect
Use pumice and a musln wheel to remove minor scratches from the surface of the appliance then use a polishing compound and muslin wheel to polish. Wash and clean the device with a brush using soap and warm water.
Additional Help & Support
We are here to support you throughout the implementation period of your new
technology. Our experienced support technicians are available M – F from 6 AM
– 5 PM PT at 800-914-8004.
Contact Information
For product assistance, please review help information at:
https://sprintray.com/digital-dentistry/
To report product issues, please contact SprintRay at:
https://support.sprintray.com/hc/en-us/requests/new
Phone: 1-800-914-8004
Manufacturer information
SprintRay Inc.
2705 Media Center Dr., Suite #100A
Los AngelesCA 90065, USA
SprintRay NightGuard Flex Resn
IFU-001_3
DCO# 1275
Effective Date05/01/2023