OGT · Oral Irrigation Kit
Dental · 21 CFR 872.6510 · Class 1
Overview
| Product Code | OGT |
|---|---|
| Device Name | Oral Irrigation Kit |
| Regulation | 21 CFR 872.6510 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
