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Patient
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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.
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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
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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.
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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 solution
to Dockstader Orthodontic Lab, Inc., also a Fresno based, full service
dental lab.
Copyright @ 2004-2005 EndSnor.com & EndSnor.net | EndSnor, LLC.
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