Endoseal - operation manual (英语, English)
ENDOSEAL is an MTA based root canal filling material with the following features:
- Hydraulic property
- Excellent sealing properties
- Superior biocompatibility
- Outstanding dimensional stability
- High radiopacity
- Easy retreatment
Tricalcium silicate, Dicalcium silicate, Tetracalcium aluminoferrite, Tricalcium aluminate
Citric acid, Zirconium oxide
This product was developed for regenerative endodontic treatments.
1. Repair of perforation
3. Root canal filling
INSTRUCTIONS FOR USE :
1. Avoid use in esthetic-sensitive areas due to possibility of discoloration, similar to other MTA products.
2. Mixing should be completed just before filling due to hardening time of 7 min.
3. Ultrasonic compaction technique is recommended to ensure good seal with ENDOSEAL.
4. Calcium hydroxide must first be used to control inflammation or bleeding, if present, prior to application of ENDOSEAL.
5. Ultrasonic vibration must be applied and limited to the neck portion of the pincette that holds the gutta-percha cone. Vibration directly applied onto the gutta-percha cone will not be sufficiently transmitted.
1. This product is intended for use by dental professionals for the intended purpose of dental root canal fillings.
2. This product must be stored in a dry place to prevent hardening by moisture contamination.
3. This product must be kept tightly closed until use to prevent hardening by moisture contamination.
4. This product should be used immediately after mixing.
PRECAUTIONS BEFORE USE:
1. Check for defects in packaging or apparent damage before use of product.
2. Do not use this product in patients with known allergies to components of product.
Do not swallow or ingest. If accidental ingestion occurs, copious amounts of water must be ingested. If nausea or illness is experienced after ingestion, seek medical attention immediately. When overfilling occurs, the material is normally tolerated well by the surrounding tissue. In cases where larger amounts of material are pressed into the canalis mandibularis, immediate surgical removal of the material has to be considered, as with all root canal materials according to standard of care for removal.
INTERACTIONS WITH OTHER DENTAL MATERIALS : Not known
ADVERSE REACTIONS : Not known
DIRECTIONS FOR USE :
Preparation of the root canal :
Prior to application of ENDOSEAL, prepare, clean, and dry the root canals to be filled using standard of care endodontic techniques.
Dosage and mixing :
Mix one ENDOSEAL capsule with 0.14cc distilled water or saline on a glass slab or a mixing pad using a plastic spatula. Mix to a homogeneous consistency.
Per standard of care, ENDOSEAL is used in combination with gutta percha, silver or titanium root canal points.
For filling techniques where most of the canal is obturated by endodontic sealing material (especially in case of open apex) :
1. Mix the measured ENDOSEAL with distilled water.
2. Place ENDOSEAL in the metal tip of a Centrix gun.
3. Fill the apical 1/3 of the canal with ENDOSEAL.
4. Pack while letting the outer part of the thick paper point to absorb excess moisture.
5. Fill the middle 1/3 of the canal with ENDOSEAL.
6. Pack while letting steril cotton pellet absorb excess moisture.
7. Fill the coronal 1/3 of the canal with ENDOSEAL.
8. Take radiograph.
For the Master-Point-Technique
1. Select the master cone that will coincide with working length.
2. Mix measured ENDOSEAL with distilled water.
3. Place ENDOSEAL in the metal tip of Centrix gun.
4. Fill the coronal 1/3 of the canal with ENDOSEAL to create a coronal plug.
5. By using lentulo spiral, insinuate ENDOSEAL in the coronal 1/3 part of the canal into the middle 1/3 of the canal.
6. Insert the master cone into the canal.
7. As you resistance is felt at the apical 1/3, apply ultrasonic vibration to the pincette that holds the master cone. Ensure that the master cone can reach to working length to make an apical plug.
a. if there is difficulty in reaching working length for the master cone, remove and place metal files that reach to working length and apply ultrasonic vibration.
b. Replace the master cone and place inside at working length while applying vibration.
8. Take radiograph.
Removal of root canal filling :
Whether ENDOSEAL is used in combination with gutta-percha points or not, root canal fillings may easily be removed using conventional techniques for the removal of gutta-percha.
Working Time: The working time is a minimum of 10 minutes at 23C.
Setting Time: The setting time is a minimum of 6 minutes at 37C.
To be stored at temperatures between 15C and 25C.
Single use only permitted.
Inadequate storage conditions will decrease the shelf life and may lead to malfunction of the product.
SHELF LIFE :
3 year from manufacture date of if storage condition recommendations are observed.
2-208, 42-10, taejanggongdan-gil, Wonju-si, Gangwon-do, Korea, 220-962
TEL : +82-33-734-0330 FAX : +82-33-746-2804