Rinse, Oral, Antibacterial (By Physical Means)

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown