Complete Denture Wax Bite Rim IFU

Dandy’s Digital Full Denture Wax Bite Rim is a digitally designed and manufactured dental appliance.  It is made from high-quality materials and crafted to provide a precise fit for optimal patient comfort.

Indications for Use

Dandy’s Digital Full Denture Wax A bite rim is a dental appliance that creates an accurate and comfortable fit for a full denture. It serves as a temporary framework to guide the bite registration process.

Contraindication

The Full Denture Wax Bite Rim should not be used in the following situations:

  • Severe gum disease or oral infections
  • Uncontrolled bleeding disorders
  • Allergy or hypersensitivity to the materials used in the device
  • Patients who are unable to follow instructions or communicate effectively

Precautions and Potential Risks of Wax Bite Rims

Using the Full Denture Wax Bite Rim carries certain risks, including potential allergic reactions and temporary discomfort. However, the benefits of using this device include improved accuracy in the denture fitting process and enhanced patient satisfaction. To ensure safe and effective use of the Digital Full Denture Wax Bite Rim, please be aware of the following:

  • This device is intended for use by dental professionals only.
  • Follow the case-specific instructions provided by Dandy carefully.
  • Do not modify or adjust the device without professional guidance.
  • Discontinue use if any discomfort or adverse reactions occur.

Directions for Use

The Full Denture Wax Bite Rim aims to provide a precise fit for the full denture, resulting in improved functionality and aesthetics. The associated procedure involves taking a bite registration to record the patient's occlusal relationship.

Setup instructions:

  • Before using the device, thoroughly wash your hands with soap and water.
  • Position the Digital Full Denture Wax Bite Rim in the patient's mouth, evaluate the fit and dimensions of the wax rim intra-orally, and adjust accordingly.
  • Border mold the periphery of the wax rim using compound, wax, or heavy body PVS material, having patients perform functional movements. (It is recommended to use PVS tray adhesive.)
  • Apply a light body wash and have patients repeat functional movements.
  • Trim any excess impression material that may be covering the occlusal or facial portion of the wax rim.
  • Adjust the wax rim for proper VDO, bite, and lip support.
  • Evaluate the "F, V," and “S” sounds to verify the dimensions of the wax rim.
  • Clearly mark the wax bite rim with the patient’s smile lines, canine lines, and midlines.
  • Also, cut notches in the occlusal and mark up the rest of the unmarked wax rim to break up the monotony of the flat wax.  This will greatly assist in capturing the 360-degree scan.
  • Capture bite registration and trim excess material away from the buccal and facial sides of the wax rim.
  • Perform a 360-degree extraoral scan of the wax bite rim(s).
  • Follow any additional instructions provided regarding specific adjustments or tasks.

Expected failure time, mode, and effect on the patient:

  • The Full Denture Wax Bite Rim is designed to withstand normal usage. However, like any dental appliance, it may eventually require replacement due to wear and tear.
  • The expected lifespan of the device can vary depending on individual factors.
  • If the device fails, it may result in discomfort, compromised bite registration, or the need for additional dental procedures.

Material Safety Data Sheets (MSDS)

Attached are the Material Safety Data Sheets for our Full Denture Materials

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