Calapex

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Calapex

Non Eugenol, Calcium Hydroxide Base Polymeric Root Canal Sealer
  • Non eugenol, Calcium hydroxide based polymeric root canal sealer
  • Two component, base & catalyst system supplied in two tubes
  • Non shrinking radiopaque formula

PACKAGING

  • 1 x 20g Cartridge, Base & Catalyst, 1 x Mixing Spatula, 1 x Mixing Pad, 1 x Instruction Manual.

1,100.00

Quantity

US FDA
The product has been extensively tested and approved by the Food and Drug Administration, USA
CDSCO Registered
CDSCO
Registered & Approved as per MDR 2017 Guidelines by Central Drugs Standard Control Organization
CE
The product is audited & approved as per CE standards and laws, and has a valid CE Certifications

INDICATIONS

  • Permanent obturation after pulp extirpation and chemomechanical preparation

PRODUCT BENEFITS

  • Radio opaque
  • Ideal for infected root canals
  • Non shrinking formulation
  • Excellent physical and biological properties
Technical Data Standard Applied
1. Mixing Time 30 Sec. ISO 6876
2. Working Time 30 Min.
3. Setting Time 45 – 60 Min.
4. Flow 17 mm
5. Solubility > 2%
6. Film Thickness 45 μm

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Instructions for use:

Mixing Calapex (Base/Catalyst Tubes) : Dispense both Base and Catalyst paste to a ratio of 1:1 volume on to a mixing pad and using the spatula mix the paste for 15-20 seconds or until a creamy homogeneous consistency is obtained. Automix Cartridge: Attach the mixing tips to the Automix Cartridge press the plunger of the cartridge to express a homogeneously mixed sealer paste. Manual Mix: Activate the plunger of the manual mix cartridge to dispense both base and Catalyst paste to a ratio of 1:1 volume on to a mixing pad and using the spatula mix the paste for 15-20 seconds or until a creamy homogeneous consistency is obtained. Application of Calapex : As a standard technique, Calapex is used together with gutta-percha or silver root canal points. When a thermoplaticized filling technique is used where most of the canal is obturated by endodontic point material, apply only a light coating of Calapex to the canal walls. For Master-Point-Technique, select a gutta-percha point with the size of the last instrument used for apical preparation. Apply Calapex to the canal walls with the help of the obturation point. Alternatively a lentulo spiral can be used. Avoid the formation of air bubbles in the material and overfilling of the canal by advancing the lentulo spiral slowly to the apex running at low speeds. Withdraw Lentulo very slowly still running at low speed. Working time 15-20 minutes. Dip disinfected and dry points into Calapex and insert them into the canal with a slow pumping motion. Calpex is packaged in a multiple dose container (Tube/Cartridge ). Opening and closing of the container does not affect the shelf life of the device. The dispensed material shall not be placed back in container and the dose once applied and used shall not be reused. Calapex is the endodontic product for every dental practice. It can be used for all established and more recent root canal sealing techniques. It is also suitable for the single point method, thermoplasticize method and all condensation techniques. The setting time of Calapex in the root canal is dependent upon the availability of moisture.

Warnings:

  1. The sealer which may cause sensitization in susceptible people. Do not use Calapex in people allergic to any components of this product.
  2. Avoid eye contact to prevent irritation. In case of contact with eyes, rinse immediately with plenty of water and seek medical attention. Avoid skin contact to prevent possible allergic response. Unset material may cause irritation and therefore contact with skin and mucous membrane should be avoided .In case of contact, immediately remove material with cotton and wash thoroughly with water and soap. In case of skin sensitization or rash, discontinue use and seek medical attention.
  3. Do not swallow or take internally. If accidental swallowing occurs, drink lots of water. If nausea or illness develops, seek medical attention.
  4. Avoid overfilling. When overfilling occurs, the material is usually tolerated very well by the surrounding tissue.

Precautions :

  1. This product is intended to be used as specifically outlined in the Instruction for Use. Any use of this product inconsistent with the Instructions for use is at the discretion and sole responsibility of the practitioner.
  2. Wear suitable protective clothing, eyewear, and gloves.
  3. The solubility and essentially basic nature of Calapex composition requires that it is used only in situations where it can be protected adequately from the intraoral environment.
  4. To achieve good results, use of a rubber dam or adequate isolation is recommended.
  5. Calapex should be mixed in equal volumes for optimum performance. The mixed material should be homogeneous and streak free prior to application.
  6. Increased humidity and elevated temperature will reduce available work time and set time.
  7. Containers should be tightly closed immediately after use.
  8. Store with original caps tightly closed in a well ventilated place at or below room temperature not exceeding 24°C. Refrigerated storage is acceptable when not in use. Allow material to reach. Room temperature prior to use. Protect from moisture. Do not freeze. Do not use after expiration date.

Contraindications:

  1. Retrograde obturation.
  2. Do not use Calapex in patients with a known allergy to any of the product’s ingredients

Storage Conditions: This product should be used at room temperature. Contact with water should be strictly avoided. Inadequate storage conditions could shorten shelf life and product performance. We recommend to store at temperatures between 10°C (50°F) and 24°C (75°F) and keep syringe cap tightly closed.

Shelf Life: 2-years from the date of manufacturing.

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