510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K232393Substantially Equivalent

BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge

Proedge Dental Products, Centennial CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232393 is the FDA 510(k) clearance record for BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge, a class I device, cleared for Proedge Dental Products, Inc. on under FDA product code QYJ (Dental Waterline Treatment Cartridge). FDA's definition for product code QYJ reads: "Intended to reduce microbial bioburden in dental unit water lines". FDA records list one 510(k) clearance for Proedge Dental Products, Inc. As of , FDA records show no recalls naming K232393.

Clearance record

Decision date
Received
(79 days to decision)
Product code
QYJ Dental Waterline Treatment Cartridge
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Applicant
Proedge Dental Products, Inc. 7042 S. Revere Pkwy., Suite 400, Centennial CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYJ

Trailing 12 months

FDA records hold no clearances under product code QYJ in the trailing twelve months.

FDA records show no clearances under product code QYJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260