ISO 13485

DPid (Dental Prosthetics Identification) may meet the U.S. Food and Drug Administration(FDA), International Organization for Standardization(ISO), and Global Harmonization Task Force(GHTF) voluntary audit report submission guidelines relating to ISO13485 requirements for traceability by providing a unique 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.

International Organization for Standardization,

U.S. Food and Drug Administration, Global Harmonization Task Force (GHTF), August 05, 2011,

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.

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