21 CFR 872.6030 — Agent, Polishing, Abrasive, Oral Cavity
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6030
Identification
An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).
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 |
|---|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 77 |
