PacDent Rodin 3D Resin Printing Materials User Guide

RODIN All-Purpose Glaze Resin
Instructions For Use Guide

Device Description

Rodin Glaze resin is a biocompatible, Class II, light-curable resin for extra oral surface characterization of prefabricated teeth and denture base resins, indirect dental  restorations made of hybrid ceramic, PMMA resin materials, and other CAD/CAM composites.

Composition

Rodin Glaze resin is comprised of a Dimethacrylate based resin, photo initiator, and a UV inhibitor. It utilizes the same resin components found in typical dental restorative light curable glazing systems.

Intended Customer

Rodin Glaze 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 properly licensed practitioner).

Intended Use

For enhancing characterization of crowns, bridges, inlays, onlays, veneers, partial and full denture arches. Rodin Glaze resin can be applied by brushing thin coat to the outer surfaces of dental restorations.

Contraindications

Avoid use of this product in patients with known allergies to acrylate, methacrylate monomers and/or acrylate, methacrylate polymers.

Mixing

Avoid vigorous mixing of the glaze before application of the product. Introducing bubbles to the resin distorts the high-shine glaze appearance.

Application Instructions

8.1 In the uncured state (green state), remove all excess remaining supports tips and make contouring adjustments to the printed restoration as needed.
8.2 Using a steam gun, remove residual debris ensuring the restoration is free of dirt and bur markings.
8.3 Dry the restoration thoroughly with compressed air prior to applying Rodin Glaze.
8.4 Carefully apply Rodin Glaze to the all areas except internal abutment cavities of the restoration using a fine tip (number 4) paint brush.
8.5 Remove excess pooled resin especially on the anatomic surfaces that can lead to high occlusion.
8.6 Light cure with an inert atmosphere (nitrogen) to fully cure the glaze. See validated light curing settings (see section 9).
8.7 Check contacts, occlusion, and fit after post curing. Remove excess glaze from the inside of restoration if necessary with glass beads or aluminum oxide (50µm particles) at PSI no greater than 15lbs of pressure. Reapply glaze if necessary and repeat steps 8.4 – 8.6.

Validated Light Curing Devices

9.1 Otoflash (recommended) – 4500 flashes w/ Nitrogen
9.2 Dreve PCU LED N2 – 15min @ 40% w/ Nitrogen
** Post curing under vacuum or with inert gas is recommended if applying light cured stains and/or glaze to fully cure surface and increase durability.

Chairside Adjustments

If making chair side adjustments, treat the restoration like a composite and use carbide burs to remove material and buff with acrylic polishing compounds to regain luster to adjusted areas.

Environment Conditions

11.1 3D photopolymer resins are very light-sensitive, sensitive to ambient office lights and sunlight from a window. Do not leave resin bottles open. Resin that has been poured into a resin tank should be covered if not used.
11.2 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.

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 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 cured before being disposed of. Pour liquid resin into a clear container and set it in direct sunlight. Once it has cured, it can be treated as waste and disposed of in the regular trash.

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 medical device.

Edition v1.3 5/27/2022
RODIN Sculpture resin

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