Can Teeth Whitening Devices Be FDA Approved Or Only Registered?


Can Teeth Whitening Devices Be FDA Approved Or Only Registered?

Having whiter teeth sounds great, but does the FDA approve teeth whiteners? The experts at GLO Science did the research and have answers to many of your questions, like:

  • How are dental devices regulated?
  • Is teeth whitening safe?
  • What are safe home teeth whitening ingredients?
  • How can I choose the best product for teeth whitening at home?
  • Which teeth whitening products should I use?

First, let's begin with the terminology you'll need to understand the details and meaning behind these answers.

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FDA Designations of Medical Devices

The Food and Drug Administration is a federal agency responsible for protecting consumers and public health. It has broad authority within the U.S. Department of Health and Human Services to regulate food, medications, biologics (like vaccines), medical devices, cosmetics and more.

Teeth whitening devices are considered medical devices by the FDA. All medical devices are placed into one of three categories based on the type and amount of risk they pose to users. Here's a breakdown of those classes:

  • Class III - These medical devices entail the highest consumer risk and must pass rigorous scientific testing before being designated "FDA Approved" and marketed to the public. Examples are mechanical heart valves and implantable infusion pumps
  • Class II - These devices pose moderate risk to consumers. To be designated "FDA Cleared," these devices must demonstrate that they are "substantially equivalent" to another device that's already on the market. Examples are dialysis machines and catheters.
  • Class I - These devices pose low risks to users and don't require pre-market testing and evaluation, other than aligning with general safety controls. Teeth whitening devices and products fall into this class, as do examination gloves and breast pumps.

Teeth Whitening Devices Can Only Be FDA Registered Not Approved

Because teeth whiteners are Class I medical devices, the FDA does not grant them approval. These devices must still be registered with the FDA, however, to show they adhere to general safety and effectiveness regulations. Once a device has complied, it can legally call itself "FDA Registered" to assure consumers it meets requirements for this low-risk category.

It's important to note that using a designation of FDA clearance or approval on devices that do not merit such claims can result in criminal prosecution from the federal government. Also, the official FDA logo is not allowed for use on any private-sector products. If you see that logo on a teeth whitening product, you should be skeptical and investigate its credentials, as "FDA-approved" teeth whitening products technically do not exist.

Is Teeth Whitening Safe?

All this talk of regulations and class of risk can seem confusing. The question remains: Are teeth whiteners safe? The best teeth whitening products are registered with the FDA, indicating they meet that agency's standards for safety and effectiveness. Looking for the "FDA Registered" phrase on a company's website is one way of helping to determine whether its teeth whitening kits are safe. If you see that a company claims that they offer "FDA-approved" teeth whitening products, consider it a red flag.

There are other aspects to consider, though, when deciding on the best product for teeth whitening at home. As a savvy consumer, you should look into different types of teeth whitening ingredients, talk to your dentist about their recommendations and do some comparison shopping before you choose.

How to Choose Teeth Whitening Products that Are Safe

1. Assess the Brand

Being registered with the FDA is only one part of demonstrating that a teeth whitening device is safe. Clinical trials provide evidence of a product that delivers on its whitening claims. Recognition from reputable organizations, like the Edison Award, also indicates stature in the professional community. Above all, make sure the company stands behind its product and will provide a refund - not just more product - if you're unhappy with it.

2. Check the Teeth Whitener Ingredients

Before you put it in your mouth, make sure the product you're considering contains safe home teeth whitening ingredients. Look for an active ingredient like hydrogen peroxide gel that has been proven safe and effective at breaking down stains without harmful side effects. Be wary of ingredients like carbamide peroxide and other so-called "active" ingredients that may not work and may even cause adverse reactions.

3. Think about Sensitivity

The most common complaint about teeth whitening products is tooth sensitivity. The best products for teeth whitening at home take care to minimize sensitivity with desensitizing agents like potassium nitrate and thick gel formulations that don't run onto your gums, where sensitivity begins. GLO Brilliant and GLO Lit accelerate the process with a patented combination of gentle warming heat and blue light teeth whitening, so you can see results with applications that last only 8 minutes, which means lowered risks of sensitivity.

4. Look for Dentist Recommendations

A product that was invented by a practicing dentist and is used in dental practices across the country has the weight of professional expertise and experience behind it. You may have seen GLO Science products advertised in your own dentist's office. Ask them whether they think these teeth whitener kits are safe.

5. Consider how it Fits into Your Lifestyle

Some teeth whitening devices are more convenient and faster-acting than others. If you don't have hours to devote to at-home teeth whitening, look for a product that:

  • Provides hands-free use so you can multitask while whitening
  • Is easy to use with Bluetooth connectivity and online resources
  • Achieves results in a manageable treatment time

6. Decide what Results You Want

Whether you're a first-time user who needs intense whitening or a regular whitener looking for a touch-up, the best teeth whitening products offer options for both. Don't believe over-the-moon claims of dazzling teeth in a single-use product. Teeth whitening requires repetition and regular maintenance.

7. Weigh the Price Point

A low-cost product at the drugstore can be enticing, but it may result in zero whitening effect, an unpleasant experience, sensitivity and an empty wallet. Investing in proven technology from a reputable brand usually yields teeth whitening best results and a better overall experience, as well as a high-quality lasting product you can use each time you need to whiten.

8. Make Sure You'll Get Support

Who will you contact if you have questions about safe home teeth whitening ingredients or how to keep your teeth white for the long haul? The best teeth whitening system for you includes customer service support you can contact in multiple ways for advice, guidance and information.

9. Find Out What Others Have to Say

Teeth Whitening Reviews from real users can offer invaluable insight into how a product performs. At GLO Science, we've put together a helpful press kit to provide more background on our product awards and press coverage along with testimonials from real users.

Have any questions about teeth whitening? Our experts at GLO Science are available to help. Don't hesitate to get in touch with our teeth whitening support team to learn more.

Can Teeth Whitening Devices Be FDA Approved Or Only Registered?