FDA product code QTT: Over The Counter Electrical Salivary Stimulatory System
QTT is the FDA product code for over the counter electrical salivary stimulatory system. It is a Class II device, regulated under 21 CFR 872.5560 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under QTT, 2 in the last five years. The average 510(k) review took 168 days (median 168).
Definition
Over the Counter Device intended to electrically stimulate a relative increase in saliva production
Classification
| Field | Value |
|---|---|
| Device name | Over The Counter Electrical Salivary Stimulatory System |
| Device class | Class II |
| Regulation | 21 CFR 872.5560 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
510(k) clearances per year for QTT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 180 |
| 2023 | 1 | 155 |
Compare with all 510(k) review times · Search every QTT clearance
Top QTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Saliwell , Ltd. | 2 | 2023-12-13 |
Most recent QTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232063 | Saliwell , Ltd. | SaliPen | 2023-12-13 | 155 |
| K220618 | Saliwell , Ltd. | SaliPen | 2022-08-30 | 180 |
Recalls for QTT devices
openFDA lists no recalls for product code QTT.
Frequently asked questions
What is FDA product code QTT?
QTT is the FDA product code for over the counter electrical salivary stimulatory system. It is a Class II device, regulated under 21 CFR 872.5560 and reviewed by the Dental panel.
What device class is QTT?
Class II, regulation 21 CFR 872.5560. Typical premarket route: 510(k).
How long does a 510(k) take for product code QTT?
Across 2 cleared submissions the average was 168 days from receipt to decision (median 168).
Which companies have the most QTT clearances?
Saliwell , Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QTT
- Run a recall and safety report across every QTT manufacturer
- Watch product code QTT 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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