Product code QYJ

Device name
Dental Waterline Treatment Cartridge
Medical specialty
Dental
Device class
1
Regulation number
872.6640
Review panel
DE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Intended to reduce microbial bioburden in dental unit water lines
Source
FDA openFDA device classification dataset

Related 510(k) Records

510(k)DeviceApplicantDecision date
K232393BluTubeĀ® Dental Unit Water Purification Cartridge (BluTubeĀ®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification CartridgeProedge Dental Products, Inc.2023-10-27