UDI & Surgical Guides

With the focus on Covid related business impacts and the delayed implementation, that some of the FDA’s Unique Device Identifier(UDI) program’s labeling requirements have become effective in the latter part of 2020 has not received as much attention as it otherwise may have. One question that has recently arisen relates to the application of UDI…

Safety and Infection Protection Guidance for Dental Laboratories and their Dental Office Clients

Q&A with Mary Borg-Bartlett and Gary D. Morgan, CDT, ASQ CQA of SafeLink Consulting, Inc. Safety of workers and patients is not an easy task in these difficult times. Dental labs must consider not only the regulatory side of protecting workers but also the practical side of how to manufacture under constraints being placed on…

OSHA and COVID-19

Eliminating hazards from COVID-19 remains a top priority for OSHA. As workplaces reopen, OSHA will continue to ensure safe and healthy conditions for America’s working men and women and has released the following: https://www.osha.gov/memos/2020-05-19/updatedinterim-enforcement-response-plan-coronavirus-disease-2019-covid-19. In geographic areas where community spread of COVID-19 has significantly decreased, OSHA will return to the inspection planning policy that OSHA…

FDA and Dental Products

For dentists and dental laboratories, the raw materials and equipment/technology used in the delivery of dental services is regulated in some manner by the U.S. Food and Drug Administration (FDA). To help dentists, dental laboratories and patients understand elements of how FDA is involved, this blog is a primer on key questions that many people…

The Coronavirus – Threat to Dentistry

The coronavirus is a poignant example of why all states should adopt dental laboratory registration and disclosure so that all dental laboratories are accountable to provide written disclosure to the dentist of material content and point of origin of all dental restorations provided to the dentist. The Center for Disease Control (CDC) says it is…