Rinse, Oral, Antibacterial (By Physical Means)
The Antibacterial Oral Rinse (Physical Means) is a mouthrinse used as an aid in the treatment of gingivitis by acting through physical rather than chemical antibacterial mechanisms. The rinse works by coating tooth and tissue surfaces with a positive charge that reduces bacterial adhesion, thereby limiting plaque accumulation and gingival inflammation. It is an FDA Class 2 device regulated under 21 CFR 872.5580 in the Dental specialty, with product code NTO, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NTO
- Device Class
- FDA class 2
- Regulation Number
- 872.5580
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.