QYJ

Dental Waterline Treatment Cartridge

Product code
QYJ
Device name
Dental Waterline Treatment Cartridge
Device class
Class 1
21 CFR
21 CFR 872.6640
Medical specialty
Dental
Marketing pathway
510(K) Exempt
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

Intended to reduce microbial bioburden in dental unit water lines

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-10-27.

NumberDecision dateApplicantDevice nameSummary
K2323932023-10-27Proedge Dental Products, Inc.BluTube® Dental Unit Water Purification Cartridge (B…PDF

1 summaries are archived here for direct download.

Official FDA classification page: QYJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).