By Humankind, Inc.

By Humankind, Inc. specializes in dental hygiene products, specifically dental floss and dental floss dispensers. These devices are designed for everyday use to help remove plaque and food debris between teeth, supporting overall oral health.

By Humankind, Inc. is based in the United States. Since its devices are manufactured domestically, they are subject to U.S. federal regulations, including classification under the FDA’s medical device framework. This means compliance with U.S. requirements is a key consideration for their products.

By Humankind, Inc.’s dental floss and floss dispensers fall under the FDA’s Class I medical device classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, though they still must meet regulatory standards to ensure safety and performance.

Yes, By Humankind, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

The Class I classification indicates that these devices are considered low-risk, but they still must comply with U.S. regulations to ensure safety and effectiveness. This classification simplifies some regulatory pathways while maintaining oversight to prevent misuse or unintended harm, particularly for consumer-use products like dental floss.