# Rinse, Oral, Antibacterial (By Physical Means)
> **Product code: NTO** · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5580
## Classification
- **FDA Product Code:** NTO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 872.5580
- **Review panel:** DE
- **Medical specialty:** Dental
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NTO)
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