SmileSaver® 2oz Aligner & Denture Cleaner - Long-Lasting Protection

Microbiological studies using accepted USP standard methods have measured the efficacy of the cleansing and freshening sprays. These have included the Short Interval Kill Test (SIKT) and the Zone of Inhibition (ZOI) test.

In addition, the Preservation Efficacy Test (PET) was used to show that the products are robust to accidental contamination during standard period of use.

The Soluria® products were first shown to protect against common bacteria, such as Salmonella typhimurium, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumonia, Listeria monocytogenes, Staphylococcus aureus, Methicillin-resistant Staphylococcus aureus, and Streptococcus pyogenes, as well as yeast, Candida albicans, and molds, Aspergillus brasiliensis and Aspergillus niger. More recent testing has shown that the Soluria® products also protect against oral bacteria and yeasts, including Streptococcus mutans, which is the main cause of dental caries, Porphyromonas gingivalis and Fusibacterium nucleatum, the key culprits in gum disease and Candida albicans which is associated with stomatitis and bad breath in denture wearers.

It is necessary to protect against potentially harmful bacteria in the biofilm that builds up on the surface of removable oral appliances, such as clear aligners, retainers, night guards and sports mouth guards.

Smilesaver® is available in a great tasting, natural spearmint flavor to suit the needs of all users and provide a fresh, minty taste that users really enjoy.

Soluria® has multiple sets of microbiological data that show that these products reduce bacteria by up to 99.9% after just 30 seconds, 60 seconds and 3 minutes of treatment. If your device is in contact with the product for longer periods, the products will continue to work.

While the possibility of contamination has been recognized for some time, the connection to getting sick was not recognized by sports officials until recently. Recent research and case studies have indicated that mouth guards can become heavily contaminated and this contamination may be linked to compromised health in certain individuals. General awareness of these issues is now becoming recognized.

Smilesaver® is the only available mouth guard cleansing and freshening spray that has naturally derived ingredients that FDA has designated as GRAS (Generally Recognized as Safe).

Commercial oral rinses contain different ingredients, such as chlorhexidine, or cetylpyridinium chloride, or alcohol. These products have been observed to have one or more negatives, which include staining of the teeth and numbing of taste sensation, which is not the case for Smilesaver® .

Thousands of individuals have tried the products and have been thoroughly satisfied with the performance. In addition, Soluria® commissioned three consumer research studies to better understand the target consumers for Smilesaver® and to assess the performance of these products after 2-weeks of consumer use. These quantitative research studies were complimented by qualitative studies in dental hygienists, dentists and orthodontists, and patients, respectively.

In summary, dental practitioners and device users overwhelmingly recognize that there is a problem with the cleanliness and freshness of removable oral devices (poor condition, bad taste and foul smell). Soluria® products scored very well (90-100%) on key attributes: “safe and effective”, “ease and convenience”, “elimination of bad breath and foul taste”, “all natural ingredients”, and “kills 99.9% bacteria”, and 75% recognized that these products attributes resulted in their improved compliance. While device users were not actively seeking out a solution to the problem of cleanliness and freshness of their removable devices, they were clearly impressed with the attributes of the products and were very interested in purchasing these specific products. Furthermore, dental professionals recognized their value to their patients and are happy to recommend them.

Every time you remove your mouth guard from your mouth or before you insert it into your mouth, just spray the device with Guard Health®. This product easily and conveniently reduces bacteria by up to 99.9% in just 30 seconds – and it tastes good!

Whenever you take out your dental or orthodontic appliances during the day to eat, drink, or brush your teeth, just spray your appliance with Smilesaver® to cleanse and freshen by reducing up to 99.9% of bacteria in just 30 seconds and enjoy that clean fresh taste!

Use it as often as necessary.

Spray your device before storage and when you remove it from storage before inserting it in your mouth.

Reduces bacteria by up to 99.9% in 30 seconds.

Got a minute, spray it!

These cleansing and freshening sprays are packaged in 30ml & 60ml containers to promote frequent use on the go. The product has a 3 year shelf life.

A natural or naturally occurring ingredient is an ingredient that is directly derived from a natural source, with minimal to no processing. Examples might include vanilla essence, rosemary extract, peppermint extract, aloe vera, and so on.

A naturally derived ingredient is an ingredient that is created from one or more materials occurring in nature. The ingredient itself is not found in nature, but it is broken down into its constituent nature identical parts when, for example, it is metabolized in the body, or hydrolyzed in the environment. Two of the cleaning ingredients in the Soluria® formula are naturally derived.

Smilesaver® is the only cleaning and freshening sprays in which all the ingredients are Generally Recognized as Safe (GRAS) by FDA. In fact, all the ingredients in the formulation can be used in food products which are digested in the body.

If you swallow some of the spray solution after spraying your appliance, it is safe to ingest based upon the FDA’s safety classification of all of its ingredients as GRAS. The body will readily metabolize the ingredients in the Soluria® sprays, including the principal ingredient, LAE, to harmless materials. This principle ingredient has been extensively tested, passing all toxicology studies and, thus, has been found to be safe and effective.

Research has shown that the principal ingredient, LAE, is hydrolyzed in the human body by means of metabolic and other biochemical processes that break down the ingredient into nature identical components common in the human diet. Specifically, once ingested, LAE is absorbed and rapidly metabolized into natural products, such as lauric acid, L-arginine, L-ornithine, urea, and carbon dioxide.

The principle ingredient, LAE, is a cationic surfactant with both cleaning functionality and an ability to reduce bacteria, fungi and molds. It is used as a food additive in, for example, non-alcoholic drinks and fruit juices, salted fish and heat treated meat products, and it is used in cosmetics and toiletries, for example, soaps, shampoos and deodorants, lending credibility to its use in Soluria® products..

The products are the only sprays which contain only FDA approved GRAS ingredients and are simply intended to cleanse and freshen removable dental appliances and mouth guards. They are not products delivering therapeutic effects in or to the mouth and so there is no “drug” approval process. The principle ingredient is widely approved for use in food and cosmetic products on a global basis.

Dr. Glass and his coworkers at Oklahoma State University Center of Health Sciences, as well as several other research groups around the world, have shown that biofilms can build up over time on removable dental devices, such as sports mouth guards and clear aligners. As sports mouth guards are worn for short time periods, and are typically stored between usage occasions under poor conditions, such devices have been shown to be highly contaminated with many classes of bacteria, fungi, yeasts and molds, including such well-known pathogens as Methicillin-resistant Staphylococcus aureus (MRSA). Further, Dr. Glass has suggested an association between contaminated mouth guards and the number and severity of lesions in the mouth and elsewhere in the body. As clear aligners are worn for approximately 22 hours per day, biofilms that build up on such devices comprise a wide range of oral bacteria, including pathogenic organisms, such as those involved in cavity formation and periodontal

disease, as well as opportunistic organism not typically found in the oral cavity. These biofilms have been suggested to reduce the mouths natural resistance to cavity formation (by decreasing pH buffering) as well as to increase the user’s susceptibility to gum problems.

The Soluria® products clean and freshen removable dental/orthodontic appliances and sports mouth guards by reducing bacteria buildup on these devices to help prevent the development of bacteria-related issues in the mouth and beyond.

None. All ingredients in the formulations are present at levels well below anything that might potentially lead to toxicity. The ingredients are widely used in foods and cosmetics. When used in Soluria® products, as intended, they are free from any reported adverse effects.

As a result of toxicological studies run primarily at Huntingdon Life Science (a global reference center specialized in toxicological evaluation), LAE has shown zero toxicity at normal use doses. The studies evaluated genetic toxicity (bacterial, lymphatic, and chromosomal), acute toxicity (oral, dermal), sub-chronic toxicity, chronic toxicity, one- and two-generation reproduction toxicity, metabolism and irritation (dermal, ocular). All the documentation is compiled in 42 volumes that describe in detail all tests performed (Lamirsa - a Spanish company – provider of LAE).

Xylitol is as sweet as sugar, but with 40% less calories. Cavity-causing bacteria ferment sugar forming acids which demineralize tooth enamel which can lead to cavities. However, they do not ferment xylitol, so it is an effective sweetener which is safe to the teeth. Xylitol can also prevent bacterial adhesion to the tooth surfaces, preventing biofilm formation and so it can be beneficial to dental health: chewing gum with xylitol and toothpastes with xylitol have been clinically proven to reduce cavities by reducing demineralization and increase re-mineralization of weakened tooth enamel.

Xylitol has no after taste and is safe for diabetics and individuals with hyperglycemia.

Xylitol has no known toxicity or carcinogenicity and is considered GRAS by FDA. Xylitol has also been approved as a food additive for foods for individuals with special dietary needs.

Our manufacturing facility is registered with FDA as our partner and contract manufacturer. It is FDA compliant, a result of stringent adherence to current Good Manufacturing

Practice (cGMP) guidelines.