Cobalt Fissure Sealant IFU

Product Description:

Cobalt Fissure Sealant is designed to cover the occlusal and lingual grooves of teeth to prevent caries. The use of Cobalt’s color-changing technology during resin curing facilitates the placement of the resin in the grooves. After curing, the product changes from pink to opaque white, allowing easy follow-up of the fissure sealant over time. It is important to note that while the presence of pink indicates incomplete curing, the color change to white does not necessarily mean full curing. The recommended curing time (30 seconds) should still be followed.

Components:

  • 1 x 3g Syringe
  • 2 x Specialized Tips

Instructions for Use:

  1. Isolation:
    Cobalt Fissure Sealant is completely hydrophobic and requires full isolation of the tooth for proper application. The tooth should be fully erupted to avoid contamination with saliva.
  2. Tooth Surface Preparation:
    Clean the tooth surface by polishing with a fluoride-free paste, and remove any debris using water and air. Note: Do not use cleaning agents containing oils or fluoride.
  3. Isolation of the Surface:
    While a rubber dam provides the best isolation, cotton rolls can also be used to isolate the area.
  4. Etching:
    Apply Cobalt Etching Gel to the enamel surface for 30 seconds on all areas requiring fissure sealant. Ensure that the etched margin extends beyond the intended sealing area. Remove the etchant using suction and rinse the surface thoroughly with water and air.Avoid contamination of the etched enamel with saliva or instruments. If contamination occurs, re-etch the surface for 5 seconds.
  5. Drying:
    Completely dry the etched surfaces using oil-free air.
  6. Bonding:
    Apply a thin layer of enamel bonding agent (Cobalt Wetting Resin) and thin it by blowing air for 15 seconds. Then, light-cure the bonding agent for 30 seconds.
  7. Sealant Application:
    Using the specialized tip, apply the sealant into the grooves, ensuring it does not overflow the etched areas. Move the syringe tip as you apply the sealant to reduce air bubbles and improve flow. A probe can also be used to aid in sealant placement.After applying the sealant, light-cure the surface for 30 seconds. For larger grooves that exceed the curing light’s head size, move the light to ensure thorough curing.

    Note: While remaining pink indicates incomplete curing, the change to opaque white does not guarantee full curing. Be sure to follow the full recommended curing time.

Warnings:

  • Uncured methacrylate resins can cause tissue sensitivity in some individuals. Avoid contact with soft tissues, and if contact occurs, wash the area thoroughly with soap and water.
  • If fissure sealant accidentally comes into contact with the eyes of the patient or practitioner, rinse with plenty of water and seek medical attention immediately.
  • Do not use the product after the expiration date.

Storage Conditions:

  • Store at 20°C-25°C.
  • Storage in temperatures above 35°C or below 10°C can cause phase separation in the formulation. Avoid prolonged exposure to these temperatures.

Manufactured by:
Fartak Andisheh Borna Company, Tehran, Iran, Tehran University of Medical Sciences.

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