Coredent

Coredent specializes in custom-made dental implantation drilling templates. These devices are designed specifically to help dental surgeons plan and execute precise implant placements by aligning with a patient’s unique anatomy. The focus is on improving accuracy during surgical procedures for dental implants.

Coredent is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA’s oversight ensures that products like Coredent’s dental implantation drilling templates meet safety and performance standards before they are listed in the FDA’s Unique Device Identifier (UDI) database.

Coredent’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices like the Coredent Surgical Guide, ensuring transparency and traceability in the healthcare supply chain.

Coredent’s dental implantation drilling templates fall under Class I device classification. This classification is typically assigned to low-risk devices that pose minimal potential harm to patients. The classification is determined by factors like the device’s intended use, risk profile, and the potential for harm if misused.