Dental Lab Regulations

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

Regulations may be one of the most important among these changes due to their financial impact upon a business. Though the amount of information can be overwhelming and confusing at times, it still needs to be addressed in order to protect and maintain control of the industry.

For example, some of the dental prosthetics and appliances manufactured by Dental Laboratories and Dental Practices may be considered Class 2 Medical Devices as outlined by the U.S. Food and Drug Administration (FDA) . This relates in part to FDA’s existing regulations outlined in Title 21, 510k, and Unique Device Identification (UDI). In addition, Medical Device ISO13485 (International Organization for Standardization) in conjunction with the Global Harmonization Task Force has initiated a voluntary audit report submission; as well as, the National Association of Dental Laboratories (NADL) offering the Dental Appliance Manufacturers Audit System (DAMAS).

A common thread among these is their commitment to establish a means of documentation, identification, and traceability to increase the recognition of quality dental prosthetic devices being manufactured for the U.S. and world markets.

DPid (Dental Prosthetics Identification) may provide support in meeting some of the requirements for these various entities through a constant source of information available to the dentist, dental laboratory, and patient, by identifying a dental prosthetic’s ownership and manufacturing data including: country of origin; contact information of dentist and dental laboratory; unique identification number; date of manufacturing and subsequent changes; and component’s listing of manufacturer, brand name, certifications, and related identifiers such as lot numbers.

DPid’s process offers fast and secure access to data that may support:

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 (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, April 01, 2012,

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

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,

http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/default.htm

FDA Unique Device Identification (UDI)

DPid (Dental Prosthetics Identification) may meet theU.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 this data 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 by knowing the origin, type, and quality of materials being used in their dental prosthetic or appliance.

Additionally, part of anFDA 2010 study to “Explore Opportunities and Challenges with the Implementation of a Unique Device Identifier System” raised concerns about its application on small dental prosthetics and appliances. DPid has addressed this 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,

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

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,

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm235962.htm

ISO 13485

DPid (Dental Prosthetics Identification) may meet the U.S. Food and Drug Administration, International Organization for Standardization, and Global Harmonization Task Force 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, http://www.iso.org/iso/home.html

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

http://www.fda.gov/InternationalPrograms/HarmonizationInitiatives/ucm114616.htm

DAMAS

DPid (Dental Prosthetics Identification) may meet the National Association of Dental Laboratories (NADL) Dental Appliance Manufacturers Audit System (DAMAS) requirements, that closely reflect the U.S. Food and Drug Administration’s Quality System / Good Manufacturing Practice (QS/GMP), for 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 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 this information may increase the dental laboratory’s efficiency and productivity in repairing or remanufacturing the dental prosthetic or appliance. It may also increase patient confidence and well-being knowing the origin, type, and quality of materials being used in their dental prosthetic or appliance.

National Association of Dental Laboratories (NADL), Dental Appliance Manufacturers Audit System (DAMAS), http://www.nadl.org/DAMAS.cfm

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.