Dental laboratory

Its been said, “The only constant in life is change” and this certainly rings true with Dental Laboratories and Dental offices. Although much remains the same in regard to the types of dental prosthetics and appliances that are manufactured, there are continuous changes in processes, materials, and regulations.

Title 21

DPid (Dental Prosthetics Identification) may support the U.S. Food and Drug Administration (FDA) 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) in the areas of documentation

510k Premarket Notification

If required, DPid (Dental Prosthetics Identification) may support the U.S. Food and Drug Administration (FDA)’s 510k requirements with the introduction of a new medical device, in the areas of documentation.

FDA UNIQUE DEVICE IDENTIFICATION (UDI)

DPid (Dental Prosthetics Identification) may support the U.S. Food and Drug Administration’s (FDA) Unique Device Identification (UDI) requirements in the areas of documentation, identification, and traceability by providing a unique identification number via a 2D Code (Data Matrix) linking to a secure database containing the dental prosthetic’s or appliance’s; 1) unique identification number, 2) country of origin, 3) contact information of dentist and dental laboratory, 4) patient identification, 5) date of manufacturing and subsequent changes, and 6) list of component’s manufacturer, brand name, certifications, and related identifiers including lot numbers.
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ISO 13485

DPid (Dental Prosthetics Identification) may support 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 of 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 of dentist and dental laboratory, 4) patient identification, 5) date of manufacturing and subsequent changes, and 6) list of component’s manufacturer, brand name, certifications, and related identifiers including lot numbers.

DAMAS

DPid (Dental Prosthetics Identification) may support the National Association of Dental Laboratories (NADL) Dental Appliance Manufacturers Audit System (DAMAS) requirements, that closely reflect the U.S. Food and Drug Administration (FDA)’s Quality System / Good Manufacturing Practice (QS/GMP), of labeling and material traceability through 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 of dentist and dental laboratory, 4) patient identification, 5) date of manufacturing and subsequent changes, and 6) list of component’s manufacturer, brand name, certifications, and related identifiers including lot numbers.

STATES MANDATING DENTURE IDENTIFICATION

According to an article titled “Arizona Joins States Requiring IDing Dentures” in the October, 2011 issue of Journal of Dental Technology*, there are a number of states that have taken steps by either recommending or mandating into law some form of dental prosthetic (typically dentures) identification. The form of identification may include the patients name, Social Security Number, driver’s license number, or a combination of these together.

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).