510k Premarket Notification

DPid (Dental Prosthetics Identification) may meet the U.S. Food and Drug Administration’s 510k requirements for the introduction of a new medical device, with respect to documentation, identification, and traceability by providing a unique 2D Code (Data Matrix) and identification number linking to a 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.

U.S. Food and Drug Administration, Medical Devices Premarket Notification (510k), September 3, 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).