21 CFR 872.3520 — Cleanser, Denture, Over The Counter
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3520
Identification
An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EFT | Cleanser, Denture, Over The Counter | 1 | 26 | |
| NUX | Cleanser, Denture, Prescription | 1 | 0 |
