Spa-Dent Inc.

Spa-Dent Inc. specializes in devices that accelerate tooth-bleaching procedures, such as portable units like the SD NATURALS. These devices are designed to enhance the effectiveness of professional teeth whitening treatments in dental offices or clinical settings.

Spa-Dent Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework.

Spa-Dent Inc.’s devices fall under the FDA’s Class I classification, which typically includes low-risk medical devices requiring minimal regulatory oversight. This classification is based on the intended use of their products—specifically, accelerating tooth-bleaching procedures—which the FDA deems to pose minimal risk to patients.

Yes, Spa-Dent 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.