FDA 510(k) Dental Devices

FDA 510(k) Dental Devices - Regulatory Overview

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.