| All rights reserved. |
Safe
| Safe Theraglow SmileMachine uses a broad spectrum, filtered Xenon based light wave generator that sends the light through a fiberoptic chord into a mouthpiece which evenly applies the whitening gel to the teeth. This has several safety advantages: * The harmful UV and infrared waves are filtered out at the source, allowing for a broader spectrum of catalyzing light to react with the proprietary oxidation reagents in the hydrogen peroxide gel. This provides both a safe, and effective oxidation catalyst. * The fiberoptic chord eliminates the risk of electricity being sent into a mouthpiece that enters your client's mouth. * The light wave is generated in the SmileMachine and then sent through a fiberoptic chord into a mouthpiece, which eliminates heat from LED bulbs that juncture in the mouthpiece. Heat can damage teeth! The fiberoptic chord and light guide eliminate that risk to your clients. LED's on the other hand often rely on heat as the primary catalyst. Numerous studies confirm that heat can permanently damage the pulp of the tooth making LED systems a potential hazard. FDA Compliance The FDA has declared “light based teeth whitening devices (CFR 872.6475)” as Class 1, Exempt devices (in the same category as microdermabrasion devices). This means that these devices can be sold without the issuance of a 510K “medical device marketing” approval, as a matter of fact, the FDA will no longer issue 510K for these devices. The attached documents scanned from the FDA website confirm the information above. However, the devices must still be manufactured according to FDA standards under GMP (good manufacturing practices), in an FDA licensed facility and be properly labeled. The Theraglow SmileMachine's FDA registration number for the manufacturing facility is 300389862. Our hydrogen peroxide whitening gel is also made exclusively for SmileMachine and is of approx. 9% strength (roughly equivalent to 27% Carbamide peroxide). It contains a proprietary catalyst to allow it to work more quickly in combination with our special light source. Our proprietary gel also contains special ingredients that minimize sensitivity to the teeth, gums and lips. |
| Contact Us for More Information If you would like to learn more about our Dermaglow® microdermabrasion devices, Theraglow SmileMachine or LED light therapy machines, contact our office today. All of our professional skincare devices are designed for efficacy, dependability, styling, and affordability and our Dermaglow® microdermabrasion units and Theraglow SmileMachines are covered by a lifetime Warranty and Service contract for Life. 651 Canyon Road | Novato, California 94947 | Toll Free: 888.451.1758 |
 | |  | |  | |  | |  | |  | |  |
