Dental Handpieces and Other Devices Attached to Air and Waterlines

FDA maintains a searchable database of devices intended for human use that must follow certain FDA regulations to be clearedexternal icon for commercial distribution in the United States. Dental health care personnel can visit this site and search by multiple characteristics, such as device or applicant name.

In 2015, FDA released updated guidance for reprocessing medical devices in health care settings pdf icon[PDF – 805KB]external icon. This guidance gives manufacturers of reusable medical devices recommendations on how to write and scientifically validate reprocessing instructions. Reusable devices that received FDA clearance before 2015 might not have reprocessing instructions that meet the requirements of the 2015 guidance. According to FDA, “reprocessing instructions for some older, legally-marketed, reusable devices may not be consistent with state-of-the-art science and therefore may not ensure that device is clean, disinfected, or sterile.”

Manufacturers must provide sufficient instructions on how to prepare devices for use on the next patient. If dentists are concerned about the validity of the manufacturer’s reprocessing instructions or believe that the instructions are not consistent with basic infection prevention and control principles, CDC recommends that they contact the manufacturer to request documentation of FDA clearance of the device in question. If the manufacturer is not able to provide sufficient information, dental health care personnel can contact FDA’s Office of Compliance at OCMedicalDeviceCo@fda.hhs.gov or (240) 402-7675 for assistance.