510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QYJClass I

Dental Waterline Treatment Cartridge

21 CFR 872.6640 / Dental
FDA source (opens on fda.gov)

QYJ is the FDA product code for Dental Waterline Treatment Cartridge, a class I device type, regulated under 21 CFR 872.6640. FDA's definition for this code reads: "Intended to reduce microbial bioburden in dental unit water lines". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QYJ
Device name
Dental Waterline Treatment Cartridge
FDA definition
Intended to reduce microbial bioburden in dental unit water lines
Regulation
21 CFR 872.6640
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QYJ

By decision year
1 clearance under product code QYJ with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYJ by decision year
YearClearances
20231

Applicants with the most clearances

Product code QYJ
Applicants holding the most 510(k) clearances under product code QYJ
ApplicantClearances
Proedge Dental Products1

Companies listing this code with FDA

Companies whose registered establishments list this code