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DTA hosts various in-person workshops throughout the year, usually in conjunction with major dental meetings.  These are excellent opportunities to learn about industry trends, market data, technology, regulatory issues and more.

DTA to host a new FDA Meeting and Regulatory Workshop with heavy UDI content on January 30th and 31st at the Doubletree Hotel in Silver Spring, Maryland (near Washington D.C. and the Washington Airports).

DTA members met with FDA Branch of Device and Radiography staff to discuss 510(K) submissions, the 21st Century Cures Act, as well as device reprocessing and sterilization. Unique Device Identification implementation updates for Class II Devices was also covered, along with, dental and device standards, software as a device, and cyber security concerns.

The number one takeaway from the meeting was a new interpretation from FDA staff that any medical device that does not come with proper reprocessing instructions will now be considered a single-use device, even if the manufacturer intended the device for multiple uses.

Recently, DTA hosted two back-to-back meetings with the FDA and more than 60 member companies. The first meeting was with the staff from the FDA Branch of Devices and Radiological Health and was followed the next day with a workshop dedicated to Unique Device Identification (UDI) implementation.

The exchanges with FDA staff were meaningful, lively, and very interactive. DTA attendees and FDA staff all agreed that the meeting and the information presented was of great value in helping all parties deal with the various regulatory issues affecting patient and practitioner safety.  In response to overwhelmingly positive feedback, FDA staff members indicated that they are willing to consider a follow–up event. In addition, there were many other positive takeaways from the two-day event.

Manufacturers must begin preparing to create and upload their device UDIs–specifically the device information (DI) to the GUDID website for the Sept. 24, 2016 deadline for Class II devices. During the workshop, presenters spent a lot of time discussing the pros and cons (and what is involved) when each company uploads the UDI data on the GUDID website. There was concern that the website and the FDA help desk may be overwhelmed when manufacturers start uploading information for all the Class II devices sold in the U.S. The best estimate is that 10,000 to 20,000 companies will be uploading their Class II devices starting next year.

On March 3, DTA held a meeting with the FDA Dental Branch and other FDA staff in Silver Springs, Md., to discuss accelerating 510(k) approvals, reprocessing dental devices, implementing UDI and the role of dental standards.  More than 30 industry leaders, including representatives from ADA and the Veterans Administration, participated. Attendees praised the meeting for being an unprecedented event in other medical device segments as well as a unique opportunity to hear comments from the FDA and the opportunity to have an open and spirited exchange.