Title 21

DPid (Dental Prosthetics Identification) may meet the requirements of the U.S. Food and Drug Administration Department of Health and Human Services Chapter 1, Subchapter H – Medical Devices, Part 872 Dental Devices, Title 21 requirements (and possibly areas of Current Good Manufacturing Practice [CGMP], Device History Record, and Device Master Record) 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, CFR- Code of Federal Regulations Title 21

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?cfrpart=872

U.S. Food and Drug Administration, CFR- Code of Federal Regulations Title 21, Sec. 820.40 Document Controls

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

U.S. Food and Drug Administration, CFR- Code of Federal Regulations Title 21, Sec 820.60 Identification

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.60

U.S. Food and Drug Administration, CFR- Code of Federal Regulations Title 21, Sec 820.65 Traceability

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.65

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.