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

Plaque Disclosing Agent

21 CFR 872.6855 / Dental
FDA source (opens on fda.gov)

QJC is the FDA product code for Plaque Disclosing Agent, a class I device type, regulated under 21 CFR 872.6855. FDA's definition for this code reads: "Intended to enhance visualization of the presence of plaque on tooth surfaces". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QJC
Device name
Plaque Disclosing Agent
FDA definition
Intended to enhance visualization of the presence of plaque on tooth surfaces.
Regulation
21 CFR 872.6855
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 QJC

By decision year
1 clearance under product code QJC with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QJC by decision year
YearClearances
19771

Applicants with the most clearances

Product code QJC
Applicants holding the most 510(k) clearances under product code QJC
ApplicantClearances
Evident Dental Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order