Dental— FDA advisory panel DE

12,635 FDA 510(k) clearances across 266 product codes since 1976.

By Andrew Weston — Installation Systems Engineer

The dental panel spans the full dental workflow: endosseous implants and abutments, restorative materials (composites, cements, bonding agents), impression materials and their digital replacements (intraoral scanners), orthodontic brackets and aligners, handpieces, curing lights, and dental X-ray equipment. Clear-aligner systems are a notable modern current — the sequenced-aligner product family clears through this panel and its filings track a highly competitive consumer market.

Dental implants are the panel's regulatory anchor: root-form endosseous implants are Class II with well-established special controls, which keeps a steady stream of implant-system clearances flowing from both global majors and regional manufacturers. Because dental devices skew toward materials science, the 510(k) summaries here lean heavily on bench performance data — worth remembering when you evaluate how much a "substantially equivalent" claim actually tells you about clinical behavior.

Clearances per year

last 10 years

Top product codes in the Dental panel

all codes

Recent clearances in the Dental panel

all clearances

Data sourced from openFDA. This site is unofficial and independent of the FDA.