QYJ · Class I · 21 CFR 872.6640

FDA Product Code QYJ: Dental Waterline Treatment Cartridge

Intended To Reduce Microbial Bioburden In Dental Unit Water Lines

Leading manufacturers include Proedge Dental Products, Inc..

1
Total
1
Cleared
79d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dental Waterline Treatment Cartridge Devices (Product Code QYJ)

1 devices
1–1 of 1

About Product Code QYJ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QYJ since 2023, with 1 receiving FDA clearance (average review time: 79 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QYJ devices are reviewed by the Dental panel. Browse all Dental devices →