21 CFR 872.5580 — Rinse, Oral, Antibacterial (By Physical Means)
Dental (DE) · Subpart F—Therapeutic Devices · § 872.5580
Identification
The device is assigned the generic name oral rinse to reduce the adhesion of dental plaque and is identified as a device intended to reduce the presence of bacterial plaque on teeth and oral mucosal surfaces by physical means. The device type includes those devices that act by reducing the attachment and inhibiting the growth of bacterial plaque.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | 2 | 2 | 3rd Party |
Special Controls
NTO — Rinse, Oral, Antibacterial (By Physical Means)
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.
eCFR
NTO — Rinse, Oral, Antibacterial (By Physical Means)
The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.
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