Premier Traxodent Unit Dose Hemodent Paste Retraction System Instruction Manual

premier Traxodent Unit Dose Hemodent Paste Retraction System

Traxodent® Unit Dose
Hemodent® Paste Retraction System

Product Description

Traxodent® Hemodent® Retraction System is a soft paste containing aluminum chloride to provide gingival retraction and hemostasis. The product is topically dis-pensed thru a single-use capsule and a reusable capsule dispenser.

Indications: Traxodent® has been specifically formulated to provide gingival retraction and hemostasis. It is intended for use prior to taking an impression, cementation, cavity preparation or wherever hemostasis and retraction is required.

Directions for Use:

  1. Remove a Unit Dose Traxodent retraction capsule from the individually wrapped foil pack.
  2. Firmly seat the Unit Dose retraction capsule in the Premier Unit Dose syringe dispenser
  3. Remove the sealing cap from the Unit Dose capsule tip (immediately before application only) and discard.
    Note: To prevent sharp edges modifying the capsule tip is not encouraged.
  4. For initial use, dispense a small aliquot of the Unit Dose Traxodent paste onto a mixing pad.
  5. Rinse and air dry prepared tooth. Extrude Traxodent paste slowly into the sulcus while maintaining the dispensing tip just above the sulcus and align approximately parallel to the axial plane of the tooth preparation.
    Note: Be careful not to jam dispensing tip into sulcus.
  6. Ensure the extrusion of sufficient volume of material into the sulcus and around the prepared tooth to achieve adequate tissue retraction.
    Note: For subgingival margins and maximum deflection of soft tissue, use a Premier Retraction Cap after dispensing Traxodent Paste. Press Retraction Cap onto prepared tooth. Have the patient bite down or apply pressure to cap if patient lacks opposing dentition. Optionally, a single strand of retraction cord can be placed prior to dispensing Traxodent.
  7. Allow Traxodent paste to remain in the sulcus for at least two minutes. Often, the marginal gingiva will grow pale when retraction is achieved.
    Caution: An overly long residence time may cause damage to the tissue.
  8. After hemostasis has been achieved, Traxodent Paste should be removed thoroughly by rinsing with a mixture of air-water and with the aid of saliva ejector or suction tip.
    Caution: The patient must not swallow the retraction paste.
  9. Examine treatment site to verify complete removal of the Traxodent prior to taking an impression.

Contraindications: 

  • Do not use on persons with known allergy to aluminum chloride
  • Do not use in patients with significant periodontal disease or furcation involvement.

WARNING: 

  • Do not use on persons with known allergy to aluminum chloride
  • Do not freeze.

Adverse Events:
Allergic type of reactions such as swelling, inflam-mation, irritation, and pain could occur in persons with known allergy to aluminum chloride.

Precautions:

  • Do not insert capsule dispensing tip deeply into the sulcus. Do not violate the biological width.
  • Be sure all paste is removed before taking impression to avoid inhibition of polymerization of impression material.
  • The reuse of a single-use device can expose patients and staff to cross-contamination.
  • U.S. Law restricts this device to sale by or on order of a dental professional.

Storage: 

  • Store at room temperature <28˚C / 82˚F.
  • Do not freeze.
    To obtain an SDS, visit Premier Dental at material into the sulcus and around the prepared 6) Veiller à ce qu’il y ait un volume d’extrusion

Reorder information:

9007094 – Traxodent Unit Dose 24 Traxodent Unit Dose capsules
9007089 – Premier Unit Dose
Syringe Dispensers
3 Unit Dose Syringe Dispensers

Premier® Retraction Caps 

9048255 – size 5 (60)
9048253 – size 3 (120)
9048251 – size 1 (120)
9048260 – assorted (30) 5 (15) 1 (15) 3

Premier® Dental Products Company 1710 Romano Drive,
Plymouth Meeting, PA 19462, U.S.A.
Ph: 610-239-6000 • Fax: 610-239-6171 premierdentalco.com
Made in Israel