510(k) Dental Devices

FDA 510(k) Cleared Dental Devices

This page lists all 12504 medical devices in the Dental specialty that have been submitted to the FDA through the 510(k) premarket notification process. Dental implants, drills, crowns, imaging systems and restorative materials.

• 12495 devices cleared as substantially equivalent to a predicate device.
• Average time to FDA decision: 127 days.
• Records available from 1976 to the present.
• Filter by product code using the sidebar to narrow results by device type.