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:
Most dental devices are Class I or Class II. Data sourced from FDA 510(k) public files. Updated monthly.
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 152d |
| All-time average (cleared) | 127d |
| Not Substantially Equivalent (denied) | 279d |
Recent Dental submissions have taken longer than the historical average - 152 days in the last 2 years vs 127 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 279 days before receiving a Not Substantially Equivalent determination.
This page lists all 12611 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.
This page lists 12611 medical devices in the Dental specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 12602 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:
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.
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