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EndSnor™ appliance

Intended Use Statement: The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep, and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor™ appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance.

Description of Device: The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients’ teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth.

Recommendation:

In order to determine if you are a candidate for an EndSnor™ appliance, it is recommended that you receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis before your dentist writes you a prescription for an EndSnor™ appliance.

 
Contraindications:

The EndSnor™ appliance is contraindicated for patients who:
  • have central sleep apnea
  • have severe respiratory disorders
  • have loose teeth or advanced periodontal disease
  • are under 18 years of age

Risks:

Possible Side Effects: Use of the EndSnor™ appliance may cause:

Temporary

  • Obstruction of oral breathing, remove appliance immediately if this occurs
  • Pain or soreness in the temporomandibular joint
  • Dry mouth or excessive salivation
  • Itraoral gingival or dental soreness
  • Temporary change in bite after appliance is removed in the morning

Potential Long Term Side Effects:

  • Temporomandibular Joint (TMJ) Dysfunction
  • Permanent change in bite
  • Tooth movement or changes in dental occlusion
  • Loosening of dental restorations

Benefits: EndSnor™ appliance:

  • May reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea
  • Use during travel

Warning:

  • The stainless steel parts contain Nickel (Ni). A prolonged and frequent contact may cause skin irritation and other allergic reactions in patients sensitive to nickel.
  • The acrylic is made with Methyl Methacrylate. A prolonged and frequent contact may cause skin irritation and other allergic reactions in patients sensitive to Methyl Methacrylate.
  • If you have an allergic reaction, remove your EndSnor™ appliance immediately and contact your dentist that prescribed your EndSnor™ or your personal physician for instructions on how to treat the allergic reaction.
  • Use of the EndSnor™ appliance may cause obstruction of breathing. If this occurs, remove appliance immediately.

Precautions:

  • Dentists should consider the medical history of patients, including history of asthma, breathing, or respiratory disorders, or other relevant health problems, and refer the patient to the appropriate health care provider before prescribing the EndSnor™ appliance.
  • Safety and effectiveness in children under the age of 18years old has not been established.

Operations Information:
Directions for Use:

1. Grasp EndSnor™ appliance by the labial bar.

2. Labial bar must be on the bottom, lined up with lower teeth.

3. Holding EndSnor™ appliance by the labial bar, open mouth and insert appliance, acrylic end first.

4. Bite down into EndSnor™ appliance to seat appliance in mouth.

5. Remove EndSnor™ appliances by opening your mouth, grasp labial bar, wiggle gently from side to side to release appliance retention. Once retention is released, remove from mouth.

6. If you experience any possible side effects, remove EndSnor™ appliance, call the dentist that prescribed your EndSnor™ appliance to discuss the side effect and what actions you should take.

7. If reduction in the incidence of snoring and/or mild to moderate sleep apnea does not occur, contact your dentist that prescribed your EndSnor™ appliance for instruction on how to turn the screw mechanism for mandibular adjustment. You must contact dentist that prescribed your EndSnor™ appliance for instruction before turning screw mechanism the first time!

8. Be sure to keep all appointments scheduled by your prescribing dentist to ensure the proper function and fit of your EndSnor™ appliance.

Care of EndSnor™ Appliance:

  • After removing EndSnor™ appliance, place it in your appliance box that you received when your dentist delivered the EndSnor™ appliance or a container that allows your whole EndSnor™ appliance to be submersed in either orthodontic appliance cleaner or denture cleaner. Follow the directions on the cleaner box.
  • Before using your EndSnor™ appliance rinse it for a minimum of 2 minutes under cold running water to remove all appliance cleaner residues from the appliance.

Troubleshooting:

  • If reduction in the incidence of snoring and/or mild to moderate sleep apnea does not occur, contact your dentist that prescribed your EndSnor™ appliance for instruction on how to turn the screw mechanism for mandibular adjustment.
  • Should your EndSnor™ appliance break return it to your dentist that prescribed your appliance to be repaired. Dentist must write a prescription to lab for repair.

Warranty:

Dockstader Orthodontic Lab, Inc. warranties the EndSnor™ appliance for 90 (ninety) days from the date of invoice against any defects in craftsmanship or material failure. Dockstader Orthodontic Lab, Inc. will repair or replace the EndSnor™ appliance at no cost.

EndSnor™ appliances returned after 90 (ninety) days from the date of invoice will be repaired or replaced for a fee, at the discretion of Dockstader Orthodontic Lab, Inc. The dentist will be charged a repair or replacement fee accordingly.

This warranty applies to dentist only, as this is a prescription dental appliance. The patient must return the appliance to the dentist that prescribed the EndSnor™ appliance and the dentist must return the appliance to the lab with a new prescription in order for the warranty to be valid.

User Assistance Information:

Contact the dentist that prescribed your EndSnor™ appliance, should you need assistance.

 


EndSnor is trademarked and the design legally protected.

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EndSnor™ is presented exclusively by EndSnor, LLC, a Fresno, CA based company. EndSnor, LLC exclusively contracts all manufacturing of the EndSnor™ snore and mild to moderate obstructive sleep apnea solution to Dockstader Orthodontic Lab, Inc., also a Fresno based, full service dental lab. Copyright @ 2004-2009 EndSnor.com & EndSnor.net | EndSnor, LLC.
All rights reserved.