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) → EBA — Light, Surgical Headlight

# EBA · Light, Surgical Headlight

_Dental · 21 CFR 872.4630 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA

## Overview

- **Product Code:** EBA
- **Device Name:** Light, Surgical Headlight
- **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 (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K070287](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K070287.md) | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | Feb 12, 2007 | SESE |
| [K923949](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K923949.md) | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | Oct 16, 1992 | SESE |
| [K893458](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K893458.md) | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | Jun 22, 1989 | SESE |
| [K854646](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K854646.md) | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | Mar 6, 1986 | SESE |
| [K842515](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K842515.md) | SURGICAL HEADLIGHT | Good-Lite Co. | Aug 2, 1984 | SESE |
| [K842358](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K842358.md) | ISOLIGHT | Planmeca USA, Inc. | Jul 31, 1984 | SESE |
| [K822265](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K822265.md) | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | Sep 28, 1982 | SESE |
| [K810117](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K810117.md) | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | Feb 10, 1981 | SESE |
| [K790807](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K790807.md) | METALIT | Harry J. Bosworth Co. | Aug 3, 1979 | SESE |
| [K790806](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA/K790806.md) | PORCELIT | Harry J. Bosworth Co. | Aug 3, 1979 | SESE |

## Top Applicants

- Harry J. Bosworth Co. — 2 clearances
- Sylvan Medical Fiberoptics — 1 clearance
- Planmeca USA, Inc. — 1 clearance
- Photonic Optische Gerate GmbH & Cokg — 1 clearance
- Kelleher Corp. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EBA)

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