What are the considerations for obtaining 510(k) clearance for dental devices?

FDA Cleared: When used correctly, this term refers to FDA allowing a device to market through the 510(k) process based on substantial equivalence to a legally ... Oct 24, 2023 ... 510(k) clearance is the FDA's primary regulatory process. It is ... This means that the current state of the art is no longer guaranteed. May 29, 2024 ... This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a ... Jan 29, 2025 ... 2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on ... Apr 17, 2025 ... This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... Jun 26, 2018 ... A myth that has regrettably gained some traction lately is that the FDA's clearance of a medical device under the 510(k) substantial ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... Jan 3, 2024 ... May is an incredibly variable month for FDA decision-making and I don't honestly know why. Variability means that there's a lack of consistency, ...