WARNINGS

1. Overview

This kit is designed to help you create an accurate dental impression at home. The impression will be used to fabricate a custom intraoral device intended to reduce the effects of bruxism (teeth grinding/clenching) with an integrated biofeedback component. Please read these instructions carefully before beginning the process.

2. Intended Use

Purpose: To capture a dental impression used for fabricating a custom intraoral device aimed at mitigating bruxism.

Biofeedback Component: The resulting device incorporates sensors that provide real-time feedback to help reduce bruxism behavior.

3. Important Safety Information & Warnings

Before proceeding, please note the following risks and precautions:

Dislodging Existing Dental Work:  

  – Risk: The impression process may cause temporary dislodgment of crowns, bridges, or other dental work.  

  – Mitigation: If you have any dental restorations or appliances, please inform us before use because these generally require alternative impression techniques such as through our dental professional network. Proceed gently with the impression tray; if you feel movement or discomfort near any dental work, remove the tray immediately and contact your dentist.  

Risk of Getting Stuck in the Mouth:  

  – Risk: There is a small risk that the impression tray or material may adhere or become lodged in the mouth, which could interfere with breathing or swallowing.  

  – Mitigation:  Do not use the kit if you are alone, if you have bridges or dental work that can become trapped within the material, or if you have difficulty managing the device.  Follow the instructions precisely and avoid forcing the tray into position.  If the tray feels stuck or you experience difficulty breathing/swallowing, remain calm, try to gently remove the tray, and if unsuccessful, seek immediate medical assistance.  

General Cautions:  

  – Ensure that you are in a well-lit, safe area where you can comfortably work without interruption.  

  – Use the provided gloves to maintain hygiene and reduce the risk of contamination.  

  – Do not attempt to modify or reuse any of the kit components.

4. Adverse Event Mitigation & Troubleshooting

 If Dental Work is Dislodged or Becomes Loose:

– Immediate Action: Remove the tray immediately.

– Do Not Reinsert: Do not attempt to reposition the dental work yourself.

– Contact a Professional: Call your dentist or dental provider for an evaluation as soon as possible.

 If the Tray or Material Becomes Stuck:

– Stay Calm: Do not panic if the tray or material appears to adhere to your mouth.

– Gentle Removal: Try to gently wiggle and remove the tray using steady, light pressure.

– If Unsuccessful: If the tray does not release or you experience difficulty breathing or swallowing, contact emergency services immediately.

– Follow-Up: After removal, monitor for any lingering discomfort and consult your healthcare provider if symptoms persist.

 General Troubleshooting:

– Incomplete Impression: If the impression is not complete, do not reuse the same materials. Follow the return or replacement instructions provided in your kit.

– Discomfort During Use: If you experience significant pain or discomfort during the process, stop immediately and consult a dental professional.

5. Storage and Disposal

– Storage: Keep all unused components in a cool, dry place away from direct sunlight until you are ready to use them.

– Disposal: Dispose of used impression material and disposable components according to local regulations. Do not flush any materials down the drain.

– Recycling: Refer to the packaging for information on recycling where applicable.

If further assistance is required, do not hesitate to contact our customer support team.