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Is the Water Flosser a Medical Device?

Water flossers, also known as oral irrigators, have become a popular tool in maintaining oral health. They are commonly used to clean between teeth, along the gum line, and around dental appliances like braces. But with their growing prevalence, many people wonder: is the water flosser considered a medical device?

What Makes a Device a Medical Device?

To understand whether a water flosser falls under the category of a medical device, we must first define what qualifies as a medical device. The FDA (Food and Drug Administration) categorizes medical devices as products used for diagnosing, preventing, treating, or mitigating diseases or conditions. These devices are designed for human use and often have an impact on the body’s physiological processes without relying on pharmacological or metabolic actions.

For a device to be classified as a medical device by the FDA, it must meet the following criteria:

1. Used for disease prevention or treatment.

2. Impacts physiological processes.

3. Does not rely on drugs, immunology, or metabolism.

Water Flossers: A Medical Device?

Water flossers, are designed to maintain oral health by using a stream of water to remove debris and plaque from teeth and gums. Since these devices aim to prevent gum disease, reduce plaque buildup, and improve overall dental hygiene, they fall within the scope of FDA regulation.

Water Flosser are FDA-approved, making them classified as Class I medical devices. This classification includes devices that are low risk and typically don’t require premarket approval, but still need to be registered with the FDA for commercial distribution.