21 CFR 872.3530 — Cleaner, Denture, Mechanical
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3530
Identification
A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.
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 |
|---|---|---|---|---|
| JER | Cleaner, Denture, Mechanical | 1 | 14 |
