Beutlich Pharmaceuticals, LLC

Beutlich Pharmaceuticals, LLC specializes in professional dental coatings focused on tooth desensitization. Their primary product category is dental coatings, specifically designed to address dentin sensitivity. These include liquid formulations like HurriSeal Dentin Desensitizer and swab-based applications, such as the Snap-N-Go Swab variant. These devices are intended for clinical use by dental professionals.

Beutlich Pharmaceuticals, LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance standards, particularly for devices marketed in the U.S. market.

Beutlich Pharmaceuticals, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability and regulatory compliance. This listing is specific to the devices authorized for use in the U.S.

Beutlich Pharmaceuticals, LLC’s devices fall under Class II classification. Class II devices are generally considered to pose moderate risk and require special controls to ensure their safety and effectiveness. These controls may include performance standards, post-market surveillance, or labeling requirements, depending on the specific device and its intended use.