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QuietNite Z Snoring Mouthpiece


Description

Fit this mouthpiece in 5 minutes and stop snoring tonight! It's not complicated.

This “boil and bite” mouthpiece opens the airway while you sleep to stop snoring.

Finally, you and your sleep partner will be able to enjoy sleeping together again.

Video Instructions and Fitting Video

Watch fitting video
Watch fitting video

HOW TO FIT the QNZ Snoring Mouthpiece

1. BOIL water and then pour into another container.
2. COOL the water for 60 seconds.
3. DIP and immerse the mouthpiece with the airway plug in place for 2 minutes.
Check to make sure it is not too hot before placing in your mouth.
4. FIT by removing the mouthpiece from the water, place it into your mouth, bite down, move the jaw forward slightly, and compress the softened material snugly in around your teeth and gums. You may soften and refit the mouthpiece if necessary, to improve the fit. Then sleep with a mouthpiece to verify that your snoring improves.

More fitting details are included with the product package.


QuietNite Z FAQs

How do I know that the QNZ will work for me?
Medical scientific studies validate the concept
• The QNZ mouthpiece concept has been validated with numerous medical and scientific studies.
• The AASM & ADSM recommend a snoring mouthpiece as the first treatment option to treat simple snoring and mild to
moderate obstructive sleep apnea. Please read this article for more information: http://mouthguardstore.com/articles/medical-
experts-recommend-the-snoring-mouthpiece-for-sleep-apnea-and-snoring
• Although it has been scientifically proven to help treat snoring and sleep apnea, it may not work for 100% of the people. Our
satisfaction rate with the product is better than 95%.

How does the QNZ work?
The QNZ holds your jaw forward during sleep to open the airway and stop snoring.
• The most common cause of snoring is air being passed through a partially constricted airway causing vibration of the palate
during breathing. The QNZ mouthpiece works by moving the jaw forward, which opens up the airway and stretches the palate
so the vibration is stopped or reduced.

Is there a simple test to try before I buy the QNZ?
Yes.
• You can try this. Close your mouth with your teeth together. Then try to make a snoring sound.
• Then open your mouth a little and move your jaw forward a little at a time and try to make the snoring stop. You will see that
the snoring stops or improves at some jaw position. This opening and jaw forward movement is how the mouthpiece stops your
snoring.
• The mouthpiece holds the jaw in that location while you sleep.

Is there a warranty?
Yes.
• You have 30 days from your purchase date to verify your satisfaction with the QNZ for a full refund. Please see the return
details at the end of the FAQ section

How soon will I stop snoring?
The first night
• For most people you will know the first night, if your snoring stops. If it stops your snoring for even a short while, then you know
that moving your jaw forward and holding it there will work for you. Purchasing the QNZ is an economical option to determine if
a snoring mouthpiece can help stop your snoring.
• Following the good sleep hygiene tips http://mouthguardstore.com/articles/how-to-stop-snoring-remedies found in the article
section at the mouthguardstore.com website will assure you the best chance to stop snoring.
• If you do not see improvement right away, try tweaking the QNZ with the steps described below.

How long will the QNZ last?
Six months to two years.
• There are many factors that can affect the life expectancy of your QNZ. Grinding your teeth while you sleep, how clean you
keep it and how you store it will all play a part.
• Some people regularly purchase every six months and others who come back once every two years.

The QNZ works but can I get a better mouthpiece?
Yes.
• It is important to confirm that a snoring mouthpiece can help treat your snoring. The QNZ is a very good first treatment option due
to its modest cost and easy fitting process.
• While many clients replace their QNZ with another one as they periodically wear, others upgrade to a thinner, better fitting and
more durable laboratory custom fit appliance called the QuietNite Z Elite. These are available at the mouthguardstore.com.


Will I be able to breathe through my mouth with the QNZ?
Yes.
• The QNZ has been engineered with a large front airway opening to allow you to breathe easily.


What does the properly fitted mouthpiece look like?
Edges not folded over
Material compressed to gums and teeth
Teeth indentations
White Airway Plugs lifts as jaw moves forward



ADJUSTING or TWEAKING THE MOUTHPIECE

What do I do if my snoring does not stop?
Refit “Tweak” the mouthpiece
• The QNZ is a thermo plastic mouthpiece which can be adjusted or “tweaked” several times.
• Most people can see an improvement in their snoring by tweaking the QNZ mouthpiece. Try these steps first to get
improvement before returning the mouthpiece.
• People are understandably disappointed if they find their QNZ does not work right away, but are then pleasantly surprised to
find that with a bit of “tweaking” they stop snoring

Situation: It does not work at all
This is usually caused from the jaw not being held forward enough.
Solution:
• Perform the snoring test described above. If your snoring improves with this simple test, then refit the mouthpiece and
pproximate that same jaw position that you discovered in the test.
• Refit the mouthpiece according to the initial instructions and move the jaw farther toward the front. You only want to do this as
far as necessary to prevent jaw soreness.
• You must reinsert the white airway plug before the “refit”.
• Sometimes the mouthpiece can be adjusted a little at a time as the body adjusts to the new location.

Situation: It only works at the start of the night, or falls out during the night
This is usually caused by the fit not begin tight enough to hold the jaw in its proper location throughout the night.
Solutions:
• Refit the mouthpiece and concentrate on compression of the softened material toward the gums and teeth.
• Make sure no edges are folded over after heating the mouthpiece and firmly compress the edges against your teeth and gums
during the soft material fitting phase.
• Suck out all the saliva when the device is first inserted at night.
• Some users have reported that application of denture adhesive keeps the mouthpiece in place enough to stop the snoring.
• If the snoring does stop but does not stay in long enough, then investing in a custom mouthpiece such as the QuietNite Z Elite
or a custom device from dentist may be a better solution.

Situation: It used to work, but now I’m snoring again
Some people clench their teeth during the night. This tends to stretch the mouthpiece making it loose and then does not hold the jaw in the right location.
Solution:
• First try to remold the mouthpiece or buy another QNZ if this fails or upgrade to a custom QNZ Elite.
• The QNZ was designed to be sturdy enough to resist some clenching.

Situation: My jaw muscles ache in the morning
It is common during the adjustment period to experience some jaw discomfort as the body adjusts to the stretching of the jaw ligaments. This in most cases resolves within a week or so.
Solution:
• If the problem persists, your jaw may be pushed too far forward. Then you can remold the mouthpiece with your jaw not so far
forward. Only move the jaw forward enough to improve the snoring as too much protrusion may cause jaw discomfort.

Situation: My front teeth hurt when I wake in the morning
This is a common situation caused by your front teeth holding the jaw forward during the night. For most people this disappears within a week or so.
Solution:
• Remolding the mouthpiece with the jaw pushed out less forward may solve the problem.
• Make sure that the edges do not flop over during the softening of the mouthpiece in the hot water as this can place too much
material on the front teeth.
• The custom QNZ Elite distributes the force more evenly and can be a better option if your see stop snoring success with the
regular QNZ.

How many times can I re mold the QNZ?
Four to five times
• Usually you can refit the device 4-5 times. The material begins to stiffen after that and be less pliable.

How long does it take to get used to it?
Usually overnight
• The adjustment phase obviously varies from person to person. Usually within a week or two most of the side effects have
diminished or disappeared.

How do I clean it?
Use a soft tooth brush with liquid soap.
• All QNZ products are cleaned in a similar fashion. First use a soft toothbrush with liquid soap to remove any debris. Tooth
pastes often contain abrasives which can damage the QNZ surface over time causing it to be more susceptible to staining.
• Soaking the appliance in a denture cleaner such as the Oxygone cleaner available from the MGS will gently clean the
mouthpiece and give it a fresh minty taste.

Will the mouthpiece make me gag?
Rarely
• Customers rarely mention gagging. If you have a problem with that, fit the mouthpiece and gradually wear it for a few minutes
at a time till the body adjusts to having something in place.

Why do I have so much saliva?
Saliva accumulation will decrease
• The body initially interprets the mouthpiece as a food type material which requires saliva. This is very common and dissipates
over time.

Can it help me if I have sleep Apnea?
Yes
• Almost everyone with Obstructive Sleep Apnea snores. A mouthpiece which helps stop snoring will also likely improve OSA.
• However, since this is a dangerous medical condition associated with heart disease and other problems, you should be
monitored by a sleep physician if you have sleep apnea.
• The QNZ and other mouthpieces can be prescribed by a physician or dentist trained in sleep breathing disorders.

Can I use the QNZ if I wear dentures?
Yes.
• If you have partial dentures and some front teeth in both upper and lower jaws, the QNZ may work.
No.
• If you wear a full denture in either jaw
• If you wear full dentures the QNZ will not work. You should consider the AveoTSD. Contact our technical department EM:
info@mouthguardstore.com for more advice.

Why is my QNZ rough?
Water was too hot during the fitting.
• If you place a QNZ in water that is too hot, it becomes very rough and not wearable and may need to be replaced. However,
the QNZ does lose some of its smoothness when put in hot water – even at the right temperature.

What is the difference between the QNZ and the laboratory custom mouthpiece QNZ Elite?
The Quiet Nite Elite fits better, is more comfortable and lasts longer.
• Price: The QNZ is considerably cheaper than the custom QNZ Elite or a custom device from a dentist often costing thousands
of dollars.
• Fit: The QNZ is a “boil-and-bite” mouthpiece, which means you put a thermo-plastic mold in hot water and then bite into it so
that it takes the shape of your teeth and gums.
• The custom QNZ Elite is hand-made in a laboratory using a dental impression kit. The device is made using a near perfect
impression of your teeth so fits more snugly.
• Size: The custom QNZ Elite has thinner walls and is less bulky so you aren’t as aware of it when you wear it.
• Comfort and Attachment: The QNZ grips mainly the front teeth, whereas a custom QNZ Elite grips all the teeth. This helps it to
sit more securely and comfortably on your teeth while you are asleep.
• Durability: The QuietNite Elite is made from a stronger laboratory processed material and lasts longer.

How do I get the white Airway Plug Out?
Rarely but occasionally, the final cooling will shrink lock the Airway Plug making its removal difficult.
• Solutions:
Prevention- do not allow the mouthpiece to overheat. Be sure to allow the proper amount of cooling time after boiling the water before immersion into the soaking cup. The main cause is having the water too hot when heat soaking the mouthpiece, it gets just too soft and squishy and then grips the airway plug too tightly.

If after fitting the airway plug resists easy removal, try this
• Option one
Make sure the QNZ is fully cooled. Squeeze the front outside section and rock the airway plug back and forth.
• Option two
Re-soften the mouthpiece in warm water, not boiling. Bite back into the mouthpiece exactly as before and begin to wiggle the airway plug a little at a time to prevent final cooling contraction of the material. This should make it easier to remove after final cooling.
• Option three
If you want to refit the mouthpiece later, coat the inside portion of the airway plug with Vaseline before the fitting. You still must keep the airway plug fully seated.
• Option Four
If none of the above is satisfactory, contact us for a replacement QNZ. Use the Vaseline as described above to prevent a recurrence of the issue

Need More Help with Technical Questions?
If you still need more help send your question to info@mouthguardstore.com





RETURN INFORMATION

What do I do if I tweak the QNZ and the snoring still does not stop or I am still not satisfied?
You can return the device.
• You must return the device or notify us of your intention to return the product within 30 days of the purchase order date.
• The QNZ is an easy and economical option to determine if a mouthpiece can treat your snoring and the return rate for this
device is less than 2%; so make sure you have tried everything before requesting a return.
• However, it does not work for 100% of the people for various reasons.

First: Email the following information to: info@mouthguardstore.com
• Reason you are returning the device
• We will ask that you provide us with details about the problem that you are having with the QNZ because your input helps us
improve customer satisfaction and assists product development.
• The original purchaser’s name and email address
• Order number
• Purchase date and Product purchased
• In all cases the returned product must be received no later than 60 days after the original purchase date as we are not able to
make a direct refund through PayPal..
• Note: Any return is evaluated and inspected for adherence to instruction guidelines. Inspection has shown that almost every
return was improperly fitted.

Second: Send Product back
• Pack and return your product to:
The MouthGuard Store
PO Box 551122
Ft Lauderdale, FL 33355, USA

• Be sure to include the following with your return:
Original purchase date
Order number
Product purchased
Purchaser’s email address and name
Reason the device is being returned

The Refund
• Your refund will be made through PayPal to the Email name in which the product was purchased.
• Shipping charges are not refundable.
• The refund will be made for the purchase amount of the product and can be expected within 15 business days after we receive
and inspect the returned product.


Thank you for using the QuietNite Z.

Warranty

100% Money-back guarantee
The QuietNite Z completely stops snoring for almost everyone. However, if it doesn’t work for you, simply return it within 30 days of purchase for a complete refund of the product purchase price. Contact us at info@MouthguardStore.com for return instructions.

User Responsibility
As the end user it is your responsibility to read and follow all directions and safety instructions carefully before boil and bite self- fitting or user- fit impressions.
The user of the self-fitting mouthpiece assumes all the risks and liabilities and there is no implied guarantee of safety as other variables exist beyond control of the manufacturer or retailer. Do not chew on the mouthpiece or store it near any heated surface and keep away from pets.
Consult with medical sleep professionals if you suspect that you have sleep apnea.

Safety
These mouthpieces are manufactured with FDA listed materials (EVA) that are commonly found in other devices approved for medical and mouthguard type use.
Check to make sure it is not too hot before placing in your mouth during the fitting process.

Intended use
The QuietNite Z products are intended to treat simple snoring. The QNZ is not intended to treat obstructive sleep apnea or dental conditions such as tempromandibular joint disorders (TMJ) and night time clenching, unless prescribed by a physician or dentist. However, some people may see improvement in these conditions. We are happy to fill those prescriptions for you.

Consult with your dentist or medical sleep specialist for more assistance, if your condition does not respond to this simple treatment.

QuietNite Z FDA Compliance Statement

In 1997 the FDA commissioned a dental products panel meeting, with the power to make recommendations for qualification of oral devices used to treat snoring and sleep apnea. Initially the group recommended that mouthpieces used to treat snoring only, would be classified as a Class I status, which is similar to sports mouthguards. These are the commonly used boil and bite mouthpieces.
Given that snoring may also be a sign of obstructive sleep apnea, a more serious medical condition, the group later decided to classify these mouthpieces into Class II. The class II standards for these snoring mouthpieces are more rigorous and the information provided to the consumer must be more extensive. Currently consumers can self-fabricate these devices as long as they are qualified medically and properly informed about the device use and possible other health related issues.

The consumer must receive a medical prescription for the Class II device directly form a dental or medical practitioner or otherwise be medically qualified and evaluated so as to rule out other serious sleep breathing disorders particularly obstructive sleep apnea. To purchase the QuietNite Z, the consumer is required to submit a prescription or verify their simple snoring diagnosis through a scientifically validated questionnaire.

In order to allow manufacturers to get their product out to the public more quickly and to reduce the burden of proof on the manufacturer, the FDA developed the FDA 510(k) approval process allowing devices which are “substantially equivalent” to enter the market place. In this process, if a device is of similar use, design, composition, and indication as a device currently on the market, the FDA will approve the device for consumer use. The consumer must be qualified for the product and fully informed as to the use and risks particularly for over the counter devices.

The QuietNite Z (QNZ) stop snoring mouthpiece is in compliance with the required FDA mandates as explained in the following summary.

FDA 510(k) Submission Summary

Device Trade names: QuietNite Z and others
Device Class: II
Common name: Snoring mouthpiece
Device classification name: Intraoral devices for snoring and/or obstructive sleep apnea
Regulations: 21 CFR 872.5570
Product codes: LRK Anti-Snoring Device
LQZ Jaw Repositioning Device
Summary of Substantial Equivalence
The QNZ is substantially equivalent to the currently marketed Somnoguard K061688, Vital Sleep K092942, Zippah Rx and the ZQuiet K090503 and others currently available through internet purchase.
Device description
The QNZ is an intraoral mandibular repositioning device used during sleep to alleviate snoring. The QNZ attaches to both upper and lower teeth. The QNZ advances and hold the lower jaw forward during sleep which enlarges and stiffens the airway to reduce snoring.
The QNZ uses the common boil and bite technique familiar to millions of athletes who heat and mold their protective mouthguard to fit their teeth. In this process the user softens the mouthpiece according to detailed directions provided with packaging and compresses the material to their teeth and gums while holding the jaw slightly forward.
After cooling the device maintains its shape and is used to hold the jaw open and forward during sleep to improve the snoring problem.


Indications for use
This device is intended alleviate simple snoring for adults.
Under supervision of a qualified sleep professional the QNZ may be used to treat other sleep breathing disorders such as sleep apnea.
Technology Comparison
The QNZ is similar in material composition to the Somnoguard, and Vital Sleep and uses FDA approved thermo elastic materials. The QNZ alleviates snoring by moving the jaw forward in the same manner as other snoring mouthpieces described previously. The QNZ can be self-fitted by the user in the same manner as the Vital Sleep, Somnoguard and Zyppah Rx.
Directions for use
The user sleeps with the mouthpiece to help treat snoring. For a complete description, please see the device details.
Performance Specifications
The QNZ Substantial equivalence is based on non-clinical data as it relates to the historical data of intraoral devices that reposition the jaw forward, mandibular advancement devices (MAD), to reduce or manage snoring.
The American Academy of Sleep Medicine, American Academy of Family Physicians, the American Academy of Dental Sleep Medicine and the scientific journal “Sleep and Breathing” all recommend the use of a mouthpiece for the treatment of snoring and the symptoms of mild to moderate obstructive sleep apnea.
American Academy of Sleep Medicine published in 1995 their Standards of Practice and Guidelines which demonstrated that oral appliances were effective in the management of snoring. The Journal CHEST in 1998 concluded that mandibular advancement devices (MAD) were 95% successful in reducing and/or controlling snoring.
Scientific data and clinical observations done in the US and Europe confirm that oral appliance therapy is an effective means by which snoring can be managed and that breathing arrests due to mild to moderate obstructive sleep apnea can be reduced. This benefit incorporates safety, convenience and cost. Currently there are over 300 such devices on the market now.
Summary Conclusion
The QNZ is a boil and bite MAD mouthpieces designed to treat simple snoring. The QNZ incorporates similar materials, fitting, directions, functions, and mechanism of action to several other FDA approved device such as the Somnoguard, Vital Sleep, Zyppah Rx and the ZQuiet mandibular advancement mouthpieces.

More Details of submission information are submitted with the confidential formal application. Which include:
Device Description
Indication for Use
Technology Comparisons
Directions for Use
Performance Specifications
Consumer Labeling Information
Additional Consumer Resources

Other useful consumer information is provided with product packaging and on website which sell the QNZ. Consumers can be confident that the QuietNite Z is in compliance with these FDA requirements.

Reviews: 7

Average Rating: 4.14/5 Reviews: 7
  • Larry  9/26/2013

    I am very happy with this product it works as advertised. My wife is sleeping so much better now as she is a College student in nursing school and is under a lot of stress and in need of all the sleep she can get. Her first reply to me after the first night was it works keep wearing it please.


  • Emma  3/2/2013

    Since I'm a woman who snores like a chain saw without a muffler, I can say without any exaggeration that this product works great! My family was horrified by the noise I could make while asleep. I think the dog was even sleep deprived.
    It takes a little getting used to but you may find that you actually sleep better with the QNZ.

    The fitting process is not complicated, but you do need to really try to bring your lower jaw forward and press firmly on the outside of your lips and cheeks while the appliance is pliable.

    Buying the 2-pack is great as you can keep one in your travel bag so you never are away at night without one.


  • Rick Rinehart  2/25/2013

    The Quiet Nite Z is very well made and easy to fit. But it is too small. Please make one that holds my mouth wider, about 5/8". The QNZ is more like 3/8" and doesn't do the trick. I don't mind fitting it myself. it was easy to do.

    I have a similar product I got from my dentist several years ago but it is no longer available and I have to have a backup. It is not just the snoring, it is the sleep apnea. This could be a lifesaver.

    Thanks...Rick Rinehart


  • Dan Bins  2/24/2013

    Tends to fall out of my mouth while sleeping


  • David  12/30/2012

    My wife says it works


  • Anna  7/27/2012

    Like magic, my snoring has stopped! THANK YOU


  • Karin  5/14/2012

    Thank you for such a quick follow up on my order....I did receive the QuietNite Z mouthguard and it works fantastic.....What a find!!!!




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