FDA 510(k) Dental Devices
About Dental Devices
FDA 510(k) dental devices include instruments, implants and materials used in dental diagnosis and treatment. The FDA review panel code is DE.
Common categories include:
- Dental implants and prosthetics - crowns, bridges, abutments
- Dental imaging systems - intraoral X-ray, CBCT, digital sensors
- Drills and handpieces - turbines, contra-angles, surgical motors
- Restorative materials - composites, cements, bonding agents
- Lasers - soft and hard tissue dental lasers
Most dental devices are Class I or Class II. Data sourced from FDA 510(k) public files. Updated monthly.
FDA 510(k) Cleared Dental Devices
This page lists all 12535 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.
- 12526 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.
How to use this database
This page lists 12535 medical devices in the Dental specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 12526 were cleared as substantially equivalent to a predicate device. Average FDA review time: 127 days. Records from 1976 to the present.
You can use this list to:
- Find predicate devices for a new 510(k) submission
- Verify the clearance status of a specific device
- Identify FDA product codes related to dental
- Compare similar cleared devices within this category
- Research manufacturers active in this specialty
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific dental device? Search by device name, K-number or manufacturer.
Search all Dental 510(k) devices