DeviceClearance

Product code QYJ— Dental

BluTube® Dental Unit Water Purification Cartridge (BluTube®) +1 more

Classification name
Dental Waterline Treatment Cartridge
Device class
Class 1
Regulation
21 CFR 872.6640
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended to reduce microbial bioburden in dental unit water lines”

— U.S. Food and Drug Administration, device classification record for product code QYJ under 21 CFR 872.6640, via openFDA

Market context for product code QYJ

FDA has cleared 1 device under product code QYJ, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QYJ

Recent clearances under product code QYJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.