FDA issued final guidances on September 1 for 510(k) submissions covering dental composite resin devices and dental curing lights. The Federal Register notice followed on September 2. The documents replace guidances dated October 26, 2005 and March 27, 2006. Both were published as drafts on July 12, 2024.
Each guidance covers device description, performance testing and labeling. FDA changed a few things between draft and final. The composite resin guidance clarifies which performance testing supports a shelf-life claim. The curing light guidance now specifies radiant power output at the tip rather than 2 mm from it, and drops the resin depth-of-cure measurement.
The dockets are FDA-2024-D-2511 for composites and FDA-2024-D-2512 for curing lights. A curing light submission with bench data measured 2 mm from the tip should be checked against the new method before it goes in. The 2005 and 2006 documents were the last word for two decades, so the testing sections here describe what a reviewer now expects to see.