ONE-FIL BIOCERAMIC SEALER - (2g) * 1SY EX-10-01-2026

Mediclus One Fill 2gm + Mediclus Onefil 0.5gms



Instruction to use :
-Bioceramic sealer.
-One-Fil is a premixed Bioceramic Root Canal Sealer containing Calcium Silicate compounds composition
for permanent sealing.
-It requires the presence of water to set and harden.
-It has excellent properties and biocompatibility
complied with requirement of ISO 6876:2012(E).


One-Fil is a premixed Bioceramic Root Canal Sealer containing


Calcium Silicate compounds composition for permanent sealing.
It requires the presence of water to set and harden.

▣ Setting time
within 2.5hours in root canal,
30min in 100% humidity condition.

▣ Application method
1. Before the application
- Check the expiration date and be cautious of the package

Contaminated.
- Follow the instructions before using it.
- Before the procedure, when the patient is ready,
remove the cap of the product and connect the tip.
- Be sure a protection device for the respiratory before the procedure.

2. Application
- Prior to the application of One-Fil, thoroughly prepare and irrigate
the root canal using standard endodontic techniques.
- Choose the master cone which will coincide which working length.
- Insert the tip of the syringe into the canal no deeper than the coronal
one second. Gently and smoothly dispense a small amount into
apex of the root canal.
- Insert to master cone into the canal.
- Fill the canal completely : avoid the formation of air bubbles and
overfilling of the root canal.
- Remove excess master cone and remove One-Fil form the top of the
root canal with wet cotton pellet.
- A radiograph can be taken to ensure an adequate apical seal.
If it is access to working length, thoroughly irrigate One-Fil out of the
root canal and repeat the procedure.

▣ Contraindications
1. Do not use One-Fil to a patient having allergy against Calcium Silicate.
2. Reuse of the enclosed tip can cause cross-infection, so re-use of the
tip is prohibited.

▣ Cautions
1. For dental use only.
2. It is not used in patients with a history of rash and hypersensitivity to dermatitis.
3. This product is used only for oral tissue. Be careful not to get into your eyes.
4. If you contact your skin or come into eyes, wash them several times with clean water and consult a specialist if necessary.
5. This product is prohibited for use other than its intended use. And the use of non-professionals is prohibited.
6. Observe the procedure and the precautions.
7. Keep it away from a reach of non-dental users including children, senior citizen and other.
8. Do not use after expiration date.
9. There is a risk of product damage, so don't give excessive impact.
10. Use of this product other than components is prohibited.

▣ Warning
Avoid overfilling the root canal. it may lead to patient sensitivity,
inflammation, or maxillary sinusitis.
If the extruded materials are pressed into the mandibular canal,
it may cause severe pain or dysaesthesia.
Immediate removal of the material is usually required.

▣ Storage
1. Please keep the syringe cap tightly when not using One-Fil.
2. Store in a cool place. (15~25℃)
3. Avoid exposure to direct sunlight.
* This product is sensitive to humidity,
so please be sure to seal with the cap after opening.

▣ Shelf-life
2 years from the date of manufacture

For root canal cleaning and preparation

A patented root canal cleaning and preparation gel with great chelation and lubricating effect. Dental cleanser for removal of dental pulp tissues in root canal treatment.

ADVANTAGES
-Removal of inorganic substances by chelation(EDTA-Ca²⁺)
-Easy application with lubricating action
-Provide a clean,smear-free canal wall