Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart B — Diagnostic Devices](/submissions/DE/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 872.1740](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1740) → NYH — Plaque Disclosing Kit

# NYH · Plaque Disclosing Kit

_Dental · 21 CFR 872.1740 · Class 2_

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

## Overview

- **Product Code:** NYH
- **Device Name:** Plaque Disclosing Kit
- **Regulation:** [21 CFR 872.1740](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/872.1740)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K781919](https://fda.innolitics.com/submissions/DE/subpart-b%E2%80%94diagnostic-devices/NYH/K781919.md) | PLAQUE DETECTION SYSTEM | Clairol, Inc. | Dec 4, 1978 | SESE |

## Top Applicants

- Clairol, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
