FDA Product Code KLC: Chair, Dental, With Operative Unit
Leading manufacturers include Dentis Co., Ltd..
FDA 510(k) Cleared Chair, Dental, With Operative Unit Devices (Product Code KLC)
About Product Code KLC - Regulatory Context
510(k) Submission Activity
63 total 510(k) submissions under product code KLC since 1976, with 63 receiving FDA clearance (average review time: 179 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 KLC have taken an average of 268 days to reach a decision - up from 178 days historically. Manufacturers should account for longer review timelines in current project planning.
KLC devices are reviewed by the Dental panel. Browse all Dental devices →