Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4630](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4630) → EAZ — Light, Operating, Dental

# EAZ · Light, Operating, Dental

_Dental · 21 CFR 872.4630 · Class 1_

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

## Overview

- **Product Code:** EAZ
- **Device Name:** Light, Operating, Dental
- **Regulation:** [21 CFR 872.4630](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4630)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental operating light, including the surgical headlight, is an AC-powered device intended to illuminate oral structures and operating areas.

## 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 (20 of 23)

Showing 20 most recent of 23 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K072309](/device/K072309.md) | MICROLUX/BLU | Addent, Inc. | Nov 19, 2007 | SESE |
| [K041614](/device/K041614.md) | MICROLUX DL | Addent, Inc. | Apr 4, 2005 | SESE |
| [K033033](/device/K033033.md) | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | Nov 22, 2004 | SESE |
| [K003995](/device/K003995.md) | SPECULITE/ORALLITE | Trylon Corp. | Mar 16, 2001 | SESE |
| [K926081](/device/K926081.md) | DENTAL LIGHT | Mdt Corp., Inc. | Jan 26, 1994 | SESE |
| [K935390](/device/K935390.md) | SIROLUX FANTASTIC | Pelton & Crane Co. | Dec 10, 1993 | SESE |
| [K925629](/device/K925629.md) | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | Nov 23, 1993 | SESE |
| [K923462](/device/K923462.md) | DELIGHT | Planmeca USA, Inc. | Dec 21, 1992 | SESE |
| [K912997](/device/K912997.md) | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | Oct 30, 1991 | SESE |
| [K912142](/device/K912142.md) | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | Oct 30, 1991 | SESE |
| [K902685](/device/K902685.md) | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | Sep 17, 1990 | SESE |
| [K894059](/device/K894059.md) | ISOLIGHT | Eurodent, Inc. | Sep 7, 1989 | SESE |
| [K893044](/device/K893044.md) | A-DEC DENTAL LIGHT | A-Dec, Inc. | Jul 14, 1989 | SESE |
| [K891216](/device/K891216.md) | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | Jun 2, 1989 | SESE |
| [K884223](/device/K884223.md) | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | Mar 17, 1989 | SESE |
| [K874374](/device/K874374.md) | THE WOOG ORATEST | Woog Intl. | Jan 19, 1988 | SESE |
| [K863019](/device/K863019.md) | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | Sep 29, 1986 | SESE |
| [K832919](/device/K832919.md) | OPTI-BEAM IV | Dentsply Intl. | Mar 2, 1984 | SESE |
| [K801683](/device/K801683.md) | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | Aug 4, 1980 | SESE |
| [K790984](/device/K790984.md) | KLIP-LITE | Innovators, Inc. | Oct 22, 1979 | SESE |

## Top Applicants

- Addent, Inc. — 2 clearances
- Trylon Corp. — 2 clearances
- A-Dec, Inc. — 1 clearance
- Chemetron Dental Products — 1 clearance
- Dabi-Atlante America Corp. — 1 clearance

---

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

**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