Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640) → SJH — Portable Dental Operative Unit

# SJH · Portable Dental Operative Unit

_Dental · 21 CFR 872.6640 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/SJH

## Overview

- **Product Code:** SJH
- **Device Name:** Portable Dental Operative Unit
- **Regulation:** [21 CFR 872.6640](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6640)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

## Classification Rationale

Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K254009](/device/K254009.md) | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | Sep 10, 2026 | SESE |

## Top Applicants

- Lakong Medical Devices Co., Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SJH](https://fda.innolitics.com/productcode/SJH)

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