Dental Devices Soon to Come Under FDA Marking Mandate
Items in your dentist’s office may soon need a unique device identification (UDI) label similar to those mandated by the FDA for medical devices. Not only the probes and scaling tools, but even crowns and posts for implants may soon be labeled. The reasons are similar to those listed for medical devices. Product identification, reporting, recalls and liability all can be more easily established with an identification system that is recognized around the world.
A recent article in Dentistry Today, “The FDA UDI Rule and Its Impact on Dentistry” points out that many dental providers are unaware that products they use every day, like dental floss and toothbrushes, are actually Class I medical devices. Materials for fillings or electronic cleaning equipment would be considered Class II medical devices.
According to the article, becoming informed is the first step “…as manufacturers of dental devices aggressively work to make sure that the products they make will be compliant by the respective FDA mandated dates, dental care providers are encouraged to begin to educate themselves about UDI and other government regulations that are being discussed with regards to the uses of this information in the future.”
Thanks to years of experience and one of the most comprehensive inventories of marking equipment in the industry, GT SCHMIDT is well positioned to help the manufacturers of dental equipment comply with the government standards and requirements. In fact, we have been marking dental equipment for years with items such as brand names and simple part numbers using metal dies and roll markers.
Today, for the most part, we have switched over to using lasers (either fiber or diode). Since lasers are non-contact, the integrity of the device is not compromised with either system. In addition, lasers work well on the metals most devices are made of such as stainless steel and titanium. Lasers are also capable at a high level of detail that is required to mark dental UDI labels.
Whichever form the final versions of the government rulings for dental device may take, GT SCHMIDT engineers have the experience and resources to devise the correct marking application. In fact, we are already working with dental suppliers who want to take a pro-active stance and be prepared for whatever the future might bring. If you would like to learn more about us, or start a conversation on dental UDIs, please contact us today.