JEO · Measurer, Gingival Fluid
Dental · 21 CFR 872.1500 · Class 1
Overview
| Product Code | JEO |
|---|---|
| Device Name | Measurer, Gingival Fluid |
| Regulation | 21 CFR 872.1500 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis 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.
