FDA Product Code ELL: Teeth, Porcelain
Leading manufacturers include Hangzhou Thales Medtech Co., Ltd..
FDA 510(k) Cleared Teeth, Porcelain Devices (Product Code ELL)
About Product Code ELL - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code ELL since 1977, with 39 receiving FDA clearance (average review time: 115 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under ELL have taken an average of 216 days to reach a decision - up from 112 days historically. Manufacturers should account for longer review timelines in current project planning.
ELL devices are reviewed by the Dental panel. Browse all Dental devices →