FDA Unique Device Identification (UDI)

DPid (Dental Prosthetics Identification) may meet the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) requirements with respect to documentation, identification, and traceability by providing a unique identification number via a 2D Code (Data Matrix) linking to secure database containing the dental prosthetic’s or appliance’s: 1) unique identification number, 2) country of origin, 3) contact information for the dentist and dental laboratory, 4) patient identification, 5) date of manufacture and of any subsequent changes, and 6) list of the component’s manufacturer, brand name, certifications, and related identifiers, including lot numbers.

Rapid access to data concerning origin, type, and quality of materials being used in their dental prosthetic or appliance may be helpful in identifying problems quickly and in notifying patients, dentists, and dental laboratories of concerns or recalls, thus increasing the patient’s confidence and well-being.

Additionally, an FDA 2010 study to “Explore Opportunities and Challenges with the Implementation of a Unique Device Identifier System” raised concerns about the application of UDI requirements to small dental prosthetics and appliances. DPid has addressed these concerns through its embedded unique 2D Code (Data Matrix) and Identification Card. All devices (Dental Prosthetics) may be identified regardless of size.

U.S. Food and Drug Administration, Medical Devices Unique Device Identification, September 17, 2012,

U.S. Food and Drug Administration, Results of FDA Pilot Activities to Explore Opportunities and Challenges with the Implementation of a Unique Device Identifier System, November 30, 2010,

The information found on this website is not, nor is it intended to be, legal advice. Nor does this website intend to provide an exhaustive list of all federal or state laws or regulations pertaining to dentistry or dental prosthetics. Laws vary from state to state and are constantly changing. DPID, LLC makes no representations, warranty or guarantee as to the accuracy or reliability of the information presented on this website.

To learn more about how DPid can benefit you, please explore our web site or contact us.
Thank you for considering DPid (Dental Prosthetics Identification).