21 CFR 872.1500 — Measurer, Gingival Fluid
Dental (DE) · Subpart B—Diagnostic Devices · § 872.1500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JEO | Measurer, Gingival Fluid | 1 | 0 |
