FDA Product Code KJJ: Cleanser, Root Canal
Leading manufacturers include Inter-Med, Inc. and Belport Company, Inc., Gingi-Pak.
FDA 510(k) Cleared Cleanser, Root Canal Devices (Product Code KJJ)
About Product Code KJJ - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code KJJ since 1978, with 41 receiving FDA clearance (average review time: 125 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for KJJ submissions have been consistent, averaging 129 days recently vs 125 days historically.
KJJ devices are reviewed by the Dental panel. Browse all Dental devices →