FDA product code NTO: Rinse, Oral, Antibacterial (By Physical Means)
NTO is the FDA product code for rinse, oral, antibacterial (by physical means). It is a Class II device, regulated under 21 CFR 872.5580 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under NTO. The average 510(k) review took 184 days (median 184). 1 De Novo request was granted under it. FDA has posted 2 recalls for NTO devices, 1 initiated in the last five years.
Definition
Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.
Classification
| Field | Value |
|---|---|
| Device name | Rinse, Oral, Antibacterial (By Physical Means) |
| Device class | Class II |
| Regulation | 21 CFR 872.5580 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NTO clearance
Top NTO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sinclair Pharmaceuticals Limited | 1 | 2006-05-17 |
Most recent NTO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053166 | Sinclair Pharmaceuticals Limited | SINCLAIR ORAL RINSE | 2006-05-17 | 184 |
Recalls for NTO devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-10-04.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code NTO?
NTO is the FDA product code for rinse, oral, antibacterial (by physical means). It is a Class II device, regulated under 21 CFR 872.5580 and reviewed by the Dental panel.
What device class is NTO?
Class II, regulation 21 CFR 872.5580. Typical premarket route: 510(k).
How long does a 510(k) take for product code NTO?
Across 1 cleared submissions the average was 184 days from receipt to decision (median 184).
Which companies have the most NTO clearances?
Sinclair Pharmaceuticals Limited (1).
Have NTO devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2023-10-04.
Next steps
- Run an FDA pathway report with predicate devices for product code NTO
- Run a recall and safety report across every NTO manufacturer
- Watch product code NTO 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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