PacDent Rodin 3D Resin Bite Tray User Guide

PacDent Rodin 3D Resin Bite Tray

1. Material Description
   Rodin Bite Tray is a biocompatible, Class I, filled resin for use in fabricating high-strength full and quadrant maxillary and mandibular arch custom or standard impression bite trays in combination with CAD/CAM systems.

2. Composition
   Rodin Bite Tray resin is comprised of a Dimethacrylate-based resin, photo initiator, inhibitor, fumed silica, and pigments. It contains resin components used in injection-molded acrylic impression tray systems.

3. Intended User
   Rodin Bite Tray resin is intended to be used only by trained professional dentists or dental lab technicians. All sales are restricted to dental supply dealers, teaching institutions and government dental facilities. This product is labeled for sales restricted to dentists (or licensed practitioner) unless state and local laws permit otherwise.

4. Intended Use
   Rodin Bite Tray resin is intended for use in the fabrication of disposable full and quadrant maxillary and mandibular arch custom or standard impression bite trays for use with Polyvinyl Siloxane (PVS), Vinyl Polysiloxane (VPS), or Alginate impression material systems. Rodin Bite Tray resin requires a computer-aided design and manufacturing (CAD/CAM) system includes the following components not part of the device: oral casting impression, digital restorative file created from a scanned impression system, stereolithographic additive printer, and curing light equipment.
   Edition v1.3 10/21/2022
   For use in tandem with validated 3D printers and post-curing devices listed below while following manufacturer’s suggested instructions.

Contraindications

• Patients allergic to methacrylate material.

Design Considerations

• Designing bite trays with a thickness below 2mm is not recommended for custom and stock tray designs. Breakage of tray and/or deformation of impression body may occur when removing tray from the patient’s mouth.
• Designing impression trays without retention holes may lead to set impression material separating from tray when removing from the patient’s mouth.

Orientation & Supporting

• Orientate both upper lower bite tray designs with adaptive tissue area side down at a 45°
  angle. Place the supports on the parameter of the ridge. Avoid placing supports in the adaptive sensitive areas which may collide with teeth and prevent tray from seating when impression taking.

• The recommended minimum support diameter is 0.3mm at the point of contact where the support meets the restoration.

• The recommended minimum support height is 2mm for ease of tray removal.

Mixing

3D printing resins contain chemicals of different weights; therefore, it is essential to thoroughly mix the resin prior to starting a new print job.
For resin already in the resin vat, use a silicon blade or spatula to gently mix resin if it has been sitting for longer than a 12-hour period.

• Before dispensing the resin from the bottle, use a plastic spatula to stir the bottom of the bottle for 1 minute minutes before dispensing or mix using an automated bottle  roller for 10 minutes.
• If the bottle has been in storage for excess of a month, it is recommended to roll the bottle for 1 hour to allow the chemical components to mix thoroughly.

Post-processing Instructions

• After completion of the print job, remove the build platform from the 3D printer.

• Wash printed trays in 99% IPA (isopropyl alcohol) using a vortex or ultrasonic bath for 5 minutes then move semi-clean parts to a secondary vortex or ultrasonic bath with fresh 99% IPA for an additional 5 minutes to complete the cleaning process.
  Note: Do not keep printed trays submerged in IPA for an extended period of time longer than 4 hours to prevent mechanical properties from degrading. Exposure to IPA exceeding 4 hours should be reprinted to ensure max strength of product.

• Use compressed air to remove excess IPA and/or residual uncured resin.

• Repeat steps 4 and 5 until the restoration is thoroughly clean leaving a shine-free, matte finish.

• Post-cure trays in a validated light curing device following recommended time and temperature schedules if applicable.
  Note:  Post curing must be performed to be in compliance with FDA.

Validated 3D Printers

• Ackuretta Sol printer.
• Carbon M1, M2, and M3 printers.

Validated Light Curing Devices

• Otoflash – Post cure at 5000 flash cycles (recommended for optimum mechanical properties).
• Dreve PCU LED N2 – 30 minutes @ 80% Light intensity
• Dreve PCU 90 – 10 minutes per side.
• Ackuretta Curie – 20min, P12, D10
• Form labs Form Cure – 15 minutes @ 60C
• Note: No inert or vacuum environment required when post curing these materials.

Chairside Adjustments and Impression Taking

• If making chair side adjustments to the bite tray, remove undesired material with standard dental carbide burs. Smooth sharp edges and remove burs with dental polishing wheels.
• Follow recommended manufacturer’s impression kit instructions when dispensing impression material and allow impression material to fully set before tray removal from patient’s mouth.

Environment Conditions

• photopolymer resins are light-sensitive and can be cured from ambient office lighting to sun light from a window. Do not leave resin bottles open to prevent contaminants and minimize light exposure. Resin that has been poured into a resin tank should be covered if not used.
• Best to store resin between 65F and 85F. Printing temp should be set to 30 degrees Celsius for optimum performance if applicable. If the bottle is stored in colder lab conditions as indicated above, it is recommended to place resin bottle with lid tightly sealed in a warm water bath prior to use.

Nightly/Long-term Storage
At the end of the day, it is best to pour unused resin from the printer back into the resin bottle for storage. When pouring resin from your tank or other vessel back into the bottle, always pour through a fine mesh filter. This will trap partially-cured debris and prevent contamination of the rest of your bottle, prolonging the life of your materials. The resin is best stored in its original container to maintain shelf-life.
Disposal
Dispose waste in accordance with all federal, state and local regulations. Consult state and local hazardous waste regulations to ensure complete and accurate classification of waste. US EPA guidelines for the classification of hazardous waste are found in 40 CFR part 261.3. Liquid resin should be fully cured before being disposed of.
Legal
Pac-Dent Inc. releases all legal liability if the end user deviates from instructional guidance and/or using invalidated equipment that may alter the function and/or performance of the appliance.

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