ADA PRODUCTS CO, INC

ADA Products Co, Inc specializes in two primary categories of dental devices: silicone dental impression materials and temporary dental crown/bridge resins. Their silicone dental impression material, branded as IS-2000, is used to create accurate molds of teeth and surrounding gum tissue for dental prosthetics. The temporary dental crown/bridge resin, called Beyond, is intended for short-term restorations during dental procedures, providing a functional solution while permanent restorations are fabricated.

ADA Products Co, Inc is based in the United States, which means their devices are subject to regulation by the U.S. Food and Drug Administration (FDA). Since their products fall under FDA Class II classification, they must comply with specific regulatory pathways, such as 510(k) clearance for market authorization and inclusion in the FDA’s Unique Device Identifier (UDI) system to ensure traceability and safety standards are met.

ADA Products Co, Inc’s devices are listed in the FDA’s 510(k) clearance database, which documents pre-market submissions for Class II medical devices, and the FDA’s Unique Device Identifier (UDI) system. These registries help track device authorization status, compliance, and manufacturing details to ensure transparency and adherence to U.S. regulatory requirements.

ADA Products Co, Inc’s devices are classified as FDA Class II medical devices. This classification indicates moderate risk, requiring special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically require pre-market notification (510(k)) clearance to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet FDA standards for dental materials and restorative procedures.