21 CFR 872.6510 — Unit, Oral Irrigation
Dental (DE) · Subpart G—Miscellaneous Devices · § 872.6510
Identification
An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.
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 |
|---|---|---|---|---|
| EFS | Unit, Oral Irrigation | 1 | 47 | |
| OGT | Oral Irrigation Kit | 1 | 0 |
