Wax Rim Instructions for Use (IFU)

Overview: This guide provides comprehensive instructions for dental professionals on the use, setup, and disposal of Dandy’s digitally designed Wax Bite Rim.

Wax Rim Indications and Contraindications

The Denture Wax Rim is a temporary framework used to guide the bite registration process and establish the Vertical Dimension of Occlusion (VDO).

Contraindications for Use

Do not use the Denture Wax Bite Rim in the following situations:

  • Severe gum disease or oral infections.

  • Uncontrolled bleeding disorders.

  • Allergy or hypersensitivity to the materials used in the device.

  • Patients unable to follow instructions or communicate effectively.

Professional Precautions and Risks

Using the Denture Wax Bite Rim carries risks such as potential allergic reactions and temporary discomfort. Note the following safety guidelines:

  • This device is for use by dental professionals only.

  • Follow the case-specific instructions provided by Dandy.

  • Do not modify the device without professional guidance.

  • Discontinue use immediately if any adverse reactions occur.

Setup and Clinical Procedures

The clinical procedure involves taking a bite registration to record the patient's occlusal relationship.

Initial Fitting and Adjustments

  1. Position the Denture Wax Bite Rim in the patient's mouth.

  2. Evaluate the fit and dimensions intra-orally.

  3. Adjust the wax rim accordingly for proper VDO, bite, and lip support.

Border Molding and Impression

  1. Border mold the periphery of the wax rim using compound, wax, or heavy body PVS material.

  2. Have the patient perform functional movements during molding. (PVS tray adhesive is recommended).

  3. Apply a light body wash and have the patient repeat functional movements.

  4. Trim excess impression material covering the facial or occlusal portions.

Markings and Scanning Preparation

  1. Evaluate "F, V," and "S" sounds to verify dimensions.

  2. Mark the wax bite rim with the patient’s smile line, canine lines, and midline.

  3. Cut notches in the occlusal surface to break up flat areas. This helps the 360-degree scan accuracy.

  4. Capture the bite registration and trim excess material from the buccal and facial sides.

  5. Perform a 360-degree extraoral scan of the wax bite rim(s)

    1. 360 Scan Technique

Life Cycle and Disposal

The Denture Wax Bite Rim is designed for normal usage but will require replacement if wear and tear occur.

Expected Failure Modes

If the device fails, it may result in patient discomfort or compromised bite registration. The lifespan of the wax rim varies by individual patient factors.

Disposal Requirements

Handle wax rims as biohazardous waste due to contact with saliva or blood.

  • Biohazard Protocol: Use red bags and authorized carriers for disposal.

  • Incineration: Use specialized handlers for incineration or secure landfill disposal.

  • Confidentiality: Redact or destroy all patient information on lab boxes before disposal.

  • Local Rules: Always check local regulations before disposal in regular trash.

Related Information

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