Important Disclaimer and Warning

These appliances are not intended to diagnose, treat, cure, mitigate, or prevent any disease or medical condition. No medical claims are made regarding the use of these appliances. Use of these appliances is entirely at the user’s own risk and should occur only with the prior approval, supervision, and ongoing direction of a certified healthcare professional.

Do not use this appliance without explicit clearance from your healthcare provider. Use of this appliance is contraindicated and strictly prohibited if you have, or suspect you may have, any of the following conditions, including but not limited to:

• Active infections

• Open wounds, sores, or lesions of any kind

• Current or prior radiation therapy that directly affects the head or neck

• Poor dentition, including but not limited to dental decay

• Active periodontal (gum) disease

• Ill-fitting or compromised dental work, including crowns, bridges, dentures, or partial dentures

• Missing posterior (back) teeth

• Dental implants of any kind

Immediately discontinue use and consult your healthcare provider if you experience any adverse effects, including but not limited to soreness, pain, tingling, numbness, discomfort in the teeth, gums, jaw, facial tissues, or head, or if you observe any movement, shifting, or change in the position of your teeth or bite.

Use must begin with short sessions of no more than 5–10 minutes, with gradual progression only if approved by and under the supervision of your healthcare provider. Do not exceed recommended use. Never sleep with the appliance in your mouth.

Failure to follow these instructions, warnings, and contraindications may result in injury or adverse outcomes, for which the manufacturer, distributor, and provider assume no liability to the fullest extent permitted by law.

​​

​​

Facial Artery

These appliances must be used carefully. Improper placement or excessive pressure
can compress the facial artery, which supplies blood to the surrounding facial tissues.
When pressure is applied to this artery, blood flow may become restricted, increasing
the risk of tissue ischemia, discomfort, numbness, or potential soft tissue injury. For this
reason, checking blood perfusion before, during, and after application of the appliance
is an essential safety step. Monitoring perfusion helps confirm that adequate circulation
is maintained and that the appliance is not compromising vascular supply. Ensuring
proper capillary refill and tissue response can help prevent complications and promote

the safe and effective use of The Pivot and Saddle appliance.

Kenzie Therapeutics is not responsible for injuries, complications, or adverse outcomes
resulting from improper application, misuse, failure to monitor perfusion, or use of the

appliance outside of recommended guidelines.