VERICOM BC Universal RRM Premixed Root Canal Filling Material Instruction Manual

VERICOM BC Universal RRM Premixed Root Canal Filling Material

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CE marking
Distributor
Use-by date
Batch code
Consult Instructions for use
Catalogue number
Non-sterile
Medical device
Keep-dry
Temperature limit
Manufacturer
Date of manufacturer
Do not re-use
Authorized representative in the European Community

Description

BC Universal RRM is a premixed bio ceramic paste developed for pulp capping, permanent root canal repair and filling. BC Universal RRM is delivered by the capsule containing the mixture of calcium aluminosilicate cement, liquid, and several compound particles. It sets in the root without the mixing process with additional water.

Composition

• Calcium aluminosilicate compound
• Zirconium oxide
• Thickening agent

Setting Time

Setting time is under 25 minutes measured according to ISO 6876:2012. In a moist environment, the setting time could be under 10 minutes. In a dry environment, the setting time could be delayed.

Indications For Use

• Pulp Capping
• Repair of Root Perforation
• Repair of Root Resorption
• Root-end Filing
• Apexification

Recommended Procedure

Capsule

1. Prior to the application of BC Universal RRM, check the product for any damages or defects.
2. Insert the capsule into the gun and remove the capsule cap from the capsule.
3. Gently pull the trigger in order to extrude the appropriate amount of the material from the capsule. And pack the material down firmly in the treated area.
4. Depending on the application, BC Universal RRM could be applied by a capsule gun, a carrier or a spatula. After BC Universal RRM is placed, pack the material down firmly in the treated area.
5. Complete the treatment according to proper methods. Pulp Capping

[Indirect]

1. Indirect pulp capping is the best treatment for normal pulp or reversible pulpitis. Do not attempt an indirect pulp capping for irreversible pulpitis.
2. Isolate the tooth with a rubber dam and complete cavity preparation using a high speed bur.
3. Remove all infected carious area using a round bur at low speed and/or a hand excavator.
4. Before the pulp is exposed, rinse the internal surface of the cavity preparation. Remove excessive moisture or hemorrhage with a dry cotton pellet.
5. Place an adequate amount of BC Universal RRM over the floor of dentin and pack the material, expanding onto sound dentin. Remove excess with a hand excavator, a micro brush or a cotton pellet.
6. Cover BC Universal RRM with a thin layer of glass ionomer cement and extend onto lateral dentin cavity wall. Proceed the restoration according to manufacturer’s instructions.
7. If the dentin thickness of cavity floor is too thin, it is recommended to follow up the detailed changes in clinical symptoms prior to final restoration with a composite resin system.
8. After the restoration, assess the pulp vitality using an X-ray every 3~6 months.

[Direct]

1. Isolate the tooth with a rubber dam and complete cavity preparation using a high speed bur.
2. Remove all caries using a round bur at low speed and/or a hand excavator.
3. Once the pulp is exposed, rinse the cavity and pulp exposure site with NaOCl. If bleeding occurs, achieve hemostasis by placing a cotton pellet dampened with NaOCl or sterile saline gently onto the pulp exposure.
4. Place an adequate amount of BC Universal RRM over the exposure using an appropriate instrument and pack the material. Remove excess with a micro brush or a cotton pellet.
5. Cover BC Universal RRM with a thin layer of glass ionomer cement extend onto lateral dentin surrounding the exposure. Proceed the restoration according to manufacturer’s instructions.
6. It is recommended to follow up the detailed changes in clinical symptoms prior to final restoration with a composite resin system.
7. After the restoration, assess the pulp vitality using an X ray every 3~6 months.

Repair Of Root Perforation/resorption

1. Isolate the tooth with a rubber dam. Debride the root canal using suitable instruments and irrigate with NaOCl.
2. Place Ca(OH)2 in the root canal to disinfect the area for a week.
3. At the next visit, isolate the tooth using a rubber dam and remove Ca(OH)2 .
4. Control excess moisture by paper points. Isolate the root canal and Identify the perforation.
5. Apply BC Universal RRM to the perforation using the suitable instruments such as a plugger or paper points.
6. Check the adequate placement of BC Universal RRM using an X-ray. If not, remove the material and repeat the application.
7. Place a moist cotton pellet in the root canal, which is prepared by squeezing a wet cotton pellet, and seal the root canal by the temporary restoration for more than 4 hours.
8. After 4 hours or at the next visit, isolate the tooth with a rubber dam and examine if the material is fully set. If not, remove the material and repeat the application.
9. If BC Universal RRM is fully set, obturate the root canal to complete the treatment.

Root-end Filling

1. Gain access to the root-end and resect the root with a surgical bur.
2. Prepare the root-end cavity with a depth of 3~5 mm using an ultrasonic tip.
3. Isolate the area and control excess moisture with paper points. Control the hemorrhage with an appropriate method.
4. Apply BC Universal RRM to the root canal using the suitable instruments.
5. Remove excess material and clean the surface of the root.
6. Check the adequate placement of BC Universal RRM using an X ray.

Apexification

1. Isolate the tooth with a rubber dam. Debride the root canal using suitable instruments and irrigate with NaOCl.
2. Dry the root canal by paper points and place Ca(OH)2 in the root canal to disinfect the area. Seal the root canal by the temporary restoration for a week.
3. At the next visit, isolate the tooth using a rubber dam and remove Ca(OH)2. Clean the root canal using suitable instrument  and irrigate with NaOCl.
4. Apply BC Universal RRM to the root canal using the suitable instruments such as a plugger or paper points. Create a 3~5 mm apical barrier of BC Universal RRM.
5. Remove excess material and clean the surface of the root.
6. Check the adequate placement of BC Universal RRM using an X-ray. If not, remove the material and repeat the application.
7. If BC Universal RRM is fully set, obturate the root canal to complete the treatment.

Storage

1. Keep BC Universal RRM in a cool place (10~25 ℃). Avoid direct sunlight.
2. Please maintain each pouch sealed when not using BC Universal RRM.

Precautions

1. For dental use only.
2. It should be used by a dentist and dental professional. Observe the procedure and the precautions.
3. Keep it away from non-dental users such as children, senior citizens and others.
4. Avoid contact of the material with the skin and eyes. If the material contacts with the skin, remove immediately with a sponge or cotton and then, wash them under running water. In case of contact with eyes, wash them under running water immediately and seek medical attention.
5. Do not apply BC Universal RRM by excessive force into the root canal, as it can result in damages.
6. Do not use this product in patients with known allergies to ingredients of the product.
7. Check for defects in a pouch before its application. Do not use if the package is damaged.
8. Do not swallow and ingest.
9. Do not use after expiry date.
10. For a single use only. Do not re-use to prevent contamination.

Warranty

VERICOM Co., LTD. will replace product that is proven to be defective. VERICOM Co., LTD. does not accept liability for any damage or loss, direct or consequential, stemming from the use of or inability to use the product described. Before using, it is the responsibility of the user to determine the suitability of the product for its intended use. The user assumes all risk and liability in connection therewith.

References

• VERICOM Co., Ltd.

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