IRM® Intermediate Restorative Material is a polymer-reinforced zinc oxide-eugenol composition restorative

material designed for intermediate restorations intended to remain in place for no longer than one year.

IRM® Intermediate Restorative Material may also be used as a base under restorative materials and

cement that does not contain resin components.

IRM® Material complies with ISO 3107 Zinc Oxide/eugenol type II: for bases and temporary restorations.

 Indications for Use:-

IRM® Material is indicated for:-

• Intermediate (temporary, less than 1 year) direct restorative filling material
• Base material under non-resin-containing permanent restorations

 Contraindications:-

• IRM® Material is contraindicated for use with patients who have a known hypersensitivity or severe allergic reaction to eugenol.

• IRM® Material is contraindicated for use with patients who have a known hypersensitivity to polymethyl methacrylate.

• IRM Material is contraindicated for direct application to dental pulp tissue (direct pulp capping).
• IRM Material is contraindicated as a base under resin-containing adhesives, restoratives, or cement.

Delivery Forms (Some delivery forms may not be available in all countries):-

• A powder/liquid version for hand mixing
• Alternatively available as IRM® Caps™ Intermediate Restorative Material for machine mixing

 Composition:-

Powder: Zinc oxide; Poly-Methyl Methacrylate (PMMA) powder; Zinc Acetate; Pigment Liquid: Eugenol; Acetic acid

  Storage:-

Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.

• Store with the original cap (not dropper cap) tightly closed in a well-ventilated place at temperatures between 10–24 °C / 50–75 °F.
• Allow material to reach room temperature before use.
• Do not store with or near materials containing (meth)acrylate resin components.
• Do not freeze.
• Protect from moisture.
• Do not use after the expiration date.
• Do not use it if the lot number and/or expiration date are missing or illegible.

STEP-BY-STEP INSTRUCTIONS:-

3.1 Cavity Preparation

3.1.1. Isolate the field of operation in the preferred manner. A rubber dam is recommended.

3.1.2. Cavity preparation must provide for the mechanical retention of the product.

3.1.3. If caries are present, completely excavate using low-speed and/or hand instrumentation.

3.1.4. Place matrix and wedge where indicated.

3.1.5. Gently dry preparation with cotton pellet. Avoid desiccation.

3.2 Pulp Protection

In deep cavities cover the dentin close to the pulp (less than 1 mm) with a hard-setting calcium hydroxide liner (Dycal® Liner, see complete Instructions for Use).

To reduce the risk of pulp irritation

Cover dentin close to the pulp (less than 1 mm) with a hard-setting calcium hydroxide liner

(Dycal® Liner) following the manufacturer’s instructions.

3.3 Dispensing IRM® Material

3.3.1. Before dispensing, fluff powder (tumble the powder bottle) to ensure uniform bulk density of contents. Fill measuring scoop to excess without packing; then

3.3.2. Level scoop with spatula. Dispense 1 level scoop of powder onto a clean, non-absorbent mixing pad or glass slab. Larger restorations may require additional scoop(s).

3.3.3. Using the dropper cap, dispense one drop of liquid for each level scoop of powder. After dispensing liquid, replace the original cap immediately to prevent evaporation and subsequent contamination.

NOTE: Premature setting of material. Keep powder and liquid separated until ready for spatulation.

3.4 Mixing IRM® Material

3.4.1. Use a spatulation technique that quickly and thoroughly combines 50% of the dispensed powder into all the dispensed liquid.

3.4.2. Bring the remaining powder into the mix in 2 or 3 increments and spatulate thoroughly. The mix should be completed in approximately one (1) minute.

3.4.3. Technique Tips:-

• A proper mix will appear quite stiff and should be stropped (wiped vigorously) for 5 to 10 seconds.
• A proper mix results in a working consistency that is smooth and adaptable. If a dry, stiff, or rubbery mix is obtained, additional liquid may be incorporated. If a sticky and soft mix is obtained, more powder may be added. Slight increments of powder should be incorporated until proper consistency is reached.

3.5 Placement of Mixed IRM® Material

Mixed material may be carried to the preparation with a suitable placement instrument. Adapt, contour, and shape with appropriate instruments.

Technique tip: Dipping the instrument into dry powder left on the pad before using it to adapt the material will facilitate placement and minimize sticking.

3.5.1. Use as Intermediate Restorative Material

• Trim excess material. Material may be smoothed by lightly burnishing. The initial set occurs approximately 5 minutes from the start of the mix. Increased temperature, humidity, and powder/liquid ratio may accelerate the setting.
• Upon set, remove the matrix band if present. Check and adjust occlusion as needed. Additional carving or occlusal adjustment may be accomplished with a round bur. Avoid gouging material with sharp burs at high speed. Additional polishing is not recommended.
• Periodically evaluate the intermediate restoration until final restoration is indicated. The intermediate restoration should be removed and the final restoration completed within 1 year of

placement.

3.5.2. Use as Protective Base

This product is a protective base for restorative material not containing polymeric resin components (e.g. final restoration of amalgam, gold).