FDA Product Code EGS: Handpiece, Contra- And Right-angle Attachment, Dental
Leading manufacturers include Nakanishi, Inc., Premium Plus (Dongguan) Limited and Dentalez, Inc., Stardental Division.
FDA 510(k) Cleared Handpiece, Contra- And Right-angle Attachment, Dental Devices (Product Code EGS)
About Product Code EGS - Regulatory Context
510(k) Submission Activity
73 total 510(k) submissions under product code EGS since 1978, with 73 receiving FDA clearance (average review time: 153 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under EGS have taken an average of 248 days to reach a decision - up from 148 days historically. Manufacturers should account for longer review timelines in current project planning.
EGS devices are reviewed by the Dental panel. Browse all Dental devices →