Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1500](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1500) → JEO — Measurer, Gingival Fluid

# JEO · Measurer, Gingival Fluid

_Dental · 21 CFR 872.1500 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/JEO

## Overview

- **Product Code:** JEO
- **Device Name:** Measurer, Gingival Fluid
- **Regulation:** [21 CFR 872.1500](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1500)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/JEO](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/JEO)

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