FAQs




FDA: RULES, GUIDANCE, REGULATIONS AND CLASSIFICATIONS:

Q: What is an ultraviolet activator?

A. It is a device that produces ultraviolet light intended to polymerize or take off resinous dental pit and fissure sealants or restorative material by transmission of light through a rod.

The scope of this guidance includes devices that use light sources such as quarts-tungsten-halogen lamps, light emitting diodes (LED's), and xenon-plasma arcs, as well as laser energy sources.

RULE: The FDA guidance does not include heat or light sources intended exclusively for tooth bleaching procedures. These are classified under 2CFR 872.6475, Heat Source for Bleaching Teeth, product code EEG. These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations of 872.9. (This action being considered cosmetic.)

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Q: What is FDA's authority over cosmetics?

A. It is very important to understand that Congress passes the laws and govern the United States. To put those laws into effect, Congress authorizes certain government agencies, including the FDA to create and enforce the rules and regulations, but only those as authorized under the law. A change in FDA's statutory authority over cosmetics would require a full congressional vote. (It would take an act of Congress.)

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Additional information is also available at (FD&C Act, sec. 201(i)).

21 CFR 872.6070 Ultraviolet Activator for Polymerization

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COMMONLY ASKED QUESTIONS

Q: Why Twilight Teeth?

A: Twilight Teeth pioneered teeth whitening in the indoor tanning industry. We are the leaders in innovation for this type of product and although we have been imitated by other companies no other teeth whitening system offers you the most comprehensive teeth whitening system in or out of the tanning industry except of course the expensive in office treatments offered by your dentist. Whether you are using our customer support program or one of our many ways to educate your tanning customer on the benefits of whitening your teeth while they tan we believe Twilight Teeth is the best system you can offer in your tanning salon today.

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Q: Can I share my Twilight Teeth?

A: It is not recommended however, Twilight Teeth has an ingredient (alcohol) that naturally disinfects the brush every time it is placed in the container.

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Q: Can I use Twilight Teeth outside of the tanning bed?

A: YES, of course your best results will come from the accelerated properties of the U.V. light. Twilight Teeth can be used outside the tanning bed. You will find that it works as a great touch up in between tanning sessions.

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Q: Just how strong is the new Twilight Teeth Platinum 25?

A: The strongest money can buy, (other than in office visits) the formula for Platinum 25 utilizes a 25% concentration of whitening agents. Your dentist will affirm that this formula is as strong and even stronger than they supply with at home kits. Plus, Twilight Teeth employs special polymers to dry and adhere to teeth during the tanning session and whiten throughout the day long after you have left the salon.

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Q: I have sensitive teeth and have found that most systems leave me with pain after I use them. Will Twilight Teeth leave me in pain?

A: Twilight Teeth is the first to utilize a system that doesn't submerge your teeth (virtually over exposing the tooth's surface) in a tray. Twilight Teeth utilizes a polymer-based system that adheres to where you apply it and starts whitening immediately during tanning session. Although our formula is stronger than over the counter systems it is the patented technology that reduces the sensitivity down to virtually undetectable, very suitable for tanners with even the most sensitive teeth and backed by a money-back guarantee. It is a known fact most sensitivity comes from a whitening product that is applied either to the back of the tooth's surface and/or the biting/grinding surface of the teeth. This is where your top teeth meet your bottom teeth and the surface is constantly ground down making it the most susceptible to sensitivity. Twilight Teeth feels that by avoiding these areas, with our brush-on application, not only allows people with sensitive teeth to use our teeth whitener but, does so without over applying to areas that are not needed.

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Q: Why don't over-the-counter systems offer a 25% concentration of whitener?

A: One reason is shelf life. Many of the whitening products take months to make to the shelves and by offering a lower concentration of active ingredient they increase the shelf life to, in some cases, several years. It is common for a consumer to buy a product that is over a year old. Twilight Teeth has an 18-month shelf life and guarantees freshness to the vendor so you know you are using the strongest and freshest teeth whitening system available today.

Another reason is how they apply the teeth whitening gel. Most systems are VERY crude in their design. They require messy amount of gel to be placed in a tray and then squished into place only to ooze gel throughout the mouth and all over the gums and soft tissue. Even the expensive molded teeth trays made by a dentist can ooze undesired amounts of gel if the amount is too great or the customer bites down too hard on the apparatus. Most teeth whitener manufacturers keep their active ingredient down to a minimum (in some cases as little as 1.5%) so the potential for customer dissatisfaction due to sensitivity is reduced. The negative side to this is that most over the counter whitening systems rarely contain enough solution to meet expectations of the today's customer.

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Q: I have heard that the mouth contains the highest level of bacteria yet the applicator goes right back in the bottle after I have completed the application. Is this sanitary?

A: YES, Twilight Teeth contains a drying agent (alcohol) that also acts as a disinfectant.

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Q: How do I care and store my Twilight Teeth?

A: You can wash the mouthpiece in warm soapy water and store in a cool dry place away from excessive heat. Make sure applicator and gel is not exposed to heat, such as being left in a car or exposed to direct sunlight. Doing so can cause the product to be less effective.

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Q: Does Tooth Bleaching really work?

A: Yes. Almost all "Natural" teeth respond to the process. However, there are some individuals whose teeth just do not respond to any bleaching product. Research has not figured out exactly why, but there appears to be about a 2 to 3 percent non-success rate. This is thought to be due to a chemical/mineral structural difference in the teeth. Rest assured that if you or your customers fall in this 2-3% you can rely on Twilight Teeth for a full refund if not satisfied.

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Q: How many ways are there to lighten or bleach teeth?

A: There are several ways to lighten or bleach teeth. Here are three of the most popular: In-Dental-Office Procedure: Tooth bleaching using a high percentage of approximately 35% Hydrogen Peroxide. This is only done in the dental office environment. This procedure is also used in conjunction with heat or light to accelerate the whitening results. In-Home Process: Tooth bleaching using a percentage of approximately 10% to 12% carbamide peroxide. A patient is provided bleaching trays for both their upper and lower arches. They are then required to apply the bleaching gel to the trays and wear them for a prescribed duration and frequency.

Combination In-Office/In-Home Procedure: Some Dental Professionals use a combination of both In-Office and In-Home Procedure. This is done to basically use the "Power Bleaching" (name given to the In-Office Procedure) to show the patient a rapid change in tooth shade. The dentist then uses the In-Home Process to do the main whitening process. It is important to note that both procedures offered by a dentist, and that yield the most optimum results, use carbamide peroxide as the active bleaching agent.

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Q: How does Twilight Teeth work?

A: The surface of your teeth contains millions of microscopic pores. Over time, organic compounds from food, beverages, and tobacco settle into these pores and cause discoloration of the tooth enamel. Twilight Teeth removes these stains with a powerful teeth-whitening process. The active ingredient in the system is carbamide peroxide, the same active ingredient used in professional dental offices nationwide. The whitening gel penetrates the pores in the surface of the teeth and removes stains by the process of oxidation. Because carbamide peroxide is accelerated by heat, the Twilight Teeth mouthpiece works to allow the UV light which already bleaches the teeth to heat and activate the whitening gel creating an easier, faster process for whitening teeth. Twilight Teeth has addressed two specific problems that occur with other teeth whitening systems:

PROBLEM - FIT. That's right, you wouldn't think about it but, even with a professional tray made for your mouth, uneven distribution of the bleaching gel is likely. How? Even the slightest pressure variance between the tooth surface and the tray caused by biting too hard or even being too relaxed, can cause the gel to be displaced too thin to be effective.

SOLUTION - A universal mouthpiece that does not have contact with the tooth's surface yet allows the UV light / heat direct access to the surface and the heat activated gel.

BENEFIT -A more uniform result. Lower cost because it's universal. Time/money saver.

PROBLEM - GEL. Some are too low of a percentage of carbamide solution to be effective. Some are not thick enough to stay in place, and some have a undesirable taste.

SOLUTION - A thick, mint flavor, heat activated, 25% carbamide peroxide (industry leading) whitening gel.

BENEFIT - A system designed for the tanning industry. Utilizing the unique environment of tanning sessions. Offering "The Original Tanning System for the Tanning Industry."

Major difference: The enormous savings of money by not going to the dentist to have the trays made or spending the time required from other systems. Let's face it you have already allocated your time for tanning why not do two things at the same time. These savings can literally mean hundreds of dollars.

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Q: How long is the process?

A: The whitening process can be achieved through regular tanning sessions, and most people begin to see results within a few sessions. Twilight Teeth is designed to use in 10 sessions, ideally every other day. It can, however, be used every time you tan, as long as there is no irritation and you can stand the tan. It is important to note that Twilight Teeth can be used up to once a day. The system is also designed to be used between 8 and 30 minutes. If you are tanning in the 8 to 12 minute range, it would be assumed you are using a high-pressure bed. Otherwise, regular beds (low pressure) will be just as effective but may take up to 25 minutes. Continue the process until you achieve the desired level of whitening. After initial treatment, most people do touch ups twice or so a month.

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Q: Does the process work on dental restoration?

A: No. The Twilight Teeth was developed specifically to whiten natural tooth enamel. Therefore, this system will not whiten or alter any dental restoration such as fillings, crowns, veneers, bonding, or bridgework.

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Q: Will Teeth Whitening or Twilight Teeth harm the teeth?

A: No. Research continues with regard to the tooth bleaching procedure. However, research data to date shows that there is no apparent risk to the teeth.

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Q: Will Teeth Whitening or Twilight Teeth hurt the soft tissue?

A: People with periodontal disease (gum disease), or excessive caries (cavities), should be treated for these conditions prior to undergoing the vital tooth bleaching procedure or using Twilight Teeth. The active ingredient in the bleaching gel itself is safe, but if sensitivity to the soft tissue does occur it typically flags an existing problem not normally associated with the bleaching product itself, but rather with the dental or oral health condition of the person using the product.

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Q: Are there any side effects?

A: A small percentage of users experience increased sensitivity to cold, or minor gum irritation. These symptoms will subside if the user stops the process for a few days. The Twilight Teeth dental whitening gel contains natural mint oil for a pleasant flavor, and is pH balanced to reduce, and in most cases eliminate any sensitivity that might be experienced.

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Q: What happens if the bleaching gel or Twilight Teeth is ingested?

A: The Twilight Teeth formula is nontoxic. However, it is like anything else, "too much of anything is not good". In short, a person should avoid swallowing when possible. The new Twilight Teeth Platinum is a polymer base gel that dries quickly, and when used properly, there should not be enough gel to swallow.

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Q: How long will the results last?

A: Teeth whitened with Twilight Teeth will stay noticeably whiter for up to 6 months, however, periodic "touch ups" should be performed to keep your smile its brightest. Your unique combination of age, foods, beverages, smoking habits and tooth structure will influence the long-term results.

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Q: Which bleaching agent is better?

A: Virtually all dentists that do tooth bleaching use a carbamide based bleaching gel. They prefer this because it is more stable, and has been proven to yield optimum results. The fact is it is easier to control the percentage of actual peroxide using carbamide than using hydrogen peroxide. The answer is that bleaching gels that use carbamide peroxide as the active ingredient are the best.

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Q: What about "Laser Whitening"?

A: "Laser" or "high intensity light" bleaching consists of using a very strong whitening solution (usually 25% to 35% whitening agent) and "activating" the solution with a laser or other high intensity light. Because this solution is so concentrated this procedure must be undertaken in the dental office. This procedure can take up to three dental office visits or more, and may cost over $1,000. As with any professional dental whitening system, follow up treatments will be needed to insure your teeth stay vibrant and white.

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Q: Why is there such a big difference in price and strength of gel between some over-the-counter products at the store, Twilight Teeth, and the cost to have the dentist perform the procedure?

A: In simple terms, "You Get What You Pay For". In more detail terms, the facts are as follows:

Most bleaching products sold in stores uses a smaller percentage of carbamide peroxide, which is understandably less effective in actual teeth whitening. The percentage is so low mainly because it is nearly impossible to regulate the use of the gel by the consumer. If a higher concentration is used incorrectly, it may cause sensitivity and in some cases harm to the soft tissue.

The dentist uses high quality bleaching product (SAME AS Twilight Teeth) specially produced for its bleaching characteristic and safety. The dentist will also provide supervision and help to monitor your bleaching progress. In some cases, the dentist will also fabricate a custom fitted bleaching tray for both arches being treated. However, when the teeth are submerged in trays, there is more likelihood of sensitivity to the tips of teeth and soft tissue (gums).

Twilight Teeth has a 25% carbamide peroxide, which is regulated by the amount of time you are tanning in the tanning bed. It is accelerated by the heat and UV light. It is also only applied to the surface of your smile teeth and therefore, the teeth and gums are not submerged in any chemicals.

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Q: Who can benefit from Twilight Teeth?

A: Anyone from 15 to 100 who wants a more confident, vibrant smile. For those who are pregnant, considering getting pregnant or lactating, it is recommended you contact your physician before using Twilight Teeth.

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TOOTH WHITENING TIPS:

A. Only natural teeth will lighten.

B. Some stains respond better than others. Stains caused by tea, coffee, smoking, certain foods, and age stains respond more quickly.

C: If soft tissue (gums) or tooth sensitivity occur, cease using the product. These can be transient side effects and will typically subside within 1 - 3 days. If they do not, it may signify an unrelated problem and you should consult your dentist. It is important to put the mouthpiece in first, then apply the gel so as not to apply gel directly to ANY soft tissue.

D: Individuals with gingivitis, bleeding gums, or cavity-laden teeth should not use this product and should consult a dentist to ensure that optimum dental and oral heath is maintained.

E. Keep Twilight Teeth and all medicines away from children.

F. Keep out of direct sunlight and store in a cool dry place.

G. Do not wear the mouthpiece while sleeping.

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COMMONLY ASKED QUESTIONS JUST FOR SALON OWNERS

Q: What are some selling tips for my salon?

A: Twilight Teeth is a great ancillary product. You can use proven suggestion techniques. For example, "Did you know you can whiten your teeth DURING your tanning session?" OR "Would you like to whiten your teeth while you tan?" This is a great tool, as it is not a hard sell tactic and allows you to inform your customer in a low-pressure sales comment. This is also great for generating questions from your customer and everyone knows if your customer is asking questions about a product, your work is half over!

For your most skeptical customer, try selling the warranty. It is one of the best guarantees in the business, 100% refund if not satisfied! If your customer continues to be reluctant, they are more than likely just not interested.

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Official Guarantee - If after use, you are not satisfied with the results, the purchase price will be refunded upon receipt of a dated cash register receipt, any unused portion of Twilight Teeth and the mouthpiece, and the reason you are not satisfied.


WARNINGS

Do not use Twilight Teeth more than once per day. If your gums become sensitive after use, we recommend discontinuing use. This product should not be used during pregnancy or while nursing without a physician's approval. Although Twilight Teeth is nontoxic, it is always best to keep it, as well as all other beauty products, safely away from children.

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Phone:

1-866-908-3384

Email:

info@TwilightTeeth.com

Address:

P.O. Box 162113, Altamonte Springs, FL 32716