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.