FDA product code QJC: Plaque Disclosing Agent
QJC is the FDA product code for plaque disclosing agent. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QJC. The average 510(k) review took 20 days (median 20).
Definition
Intended to enhance visualization of the presence of plaque on tooth surfaces.
Classification
| Field | Value |
|---|---|
| Device name | Plaque Disclosing Agent |
| Device class | Class I |
| Regulation | 21 CFR 872.6855 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every QJC clearance
Top QJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Evident Dental Co. , Ltd. | 1 | 1977-06-20 |
Most recent QJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770990 | Evident Dental Co. , Ltd. | DENTAL PLAQUE DISCLOSING AGENT | 1977-06-20 | 20 |
Recalls for QJC devices
openFDA lists no recalls for product code QJC.
Frequently asked questions
What is FDA product code QJC?
QJC is the FDA product code for plaque disclosing agent. It is a Class I device, regulated under 21 CFR 872.6855 and reviewed by the Dental panel.
What device class is QJC?
Class I, regulation 21 CFR 872.6855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QJC?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most QJC clearances?
Evident Dental Co. , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJC
- Run a recall and safety report across every QJC manufacturer
- Watch product code QJC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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