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/submissions/DE/subpart-e%E2%80%94surgical-devices/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](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K072309.md) | MICROLUX/BLU | Addent, Inc. | Nov 19, 2007 | SESE | | [K041614](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K041614.md) | MICROLUX DL | Addent, Inc. | Apr 4, 2005 | SESE | | [K033033](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K033033.md) | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | Nov 22, 2004 | SESE | | [K003995](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K003995.md) | SPECULITE/ORALLITE | Trylon Corp. | Mar 16, 2001 | SESE | | [K926081](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K926081.md) | DENTAL LIGHT | Mdt Corp., Inc. | Jan 26, 1994 | SESE | | [K935390](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K935390.md) | SIROLUX FANTASTIC | Pelton & Crane Co. | Dec 10, 1993 | SESE | | [K925629](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K925629.md) | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | Nov 23, 1993 | SESE | | [K923462](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K923462.md) | DELIGHT | Planmeca USA, Inc. | Dec 21, 1992 | SESE | | [K912997](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K912997.md) | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | Oct 30, 1991 | SESE | | [K912142](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K912142.md) | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | Oct 30, 1991 | SESE | | [K902685](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K902685.md) | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | Sep 17, 1990 | SESE | | [K894059](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K894059.md) | ISOLIGHT | Eurodent, Inc. | Sep 7, 1989 | SESE | | [K893044](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K893044.md) | A-DEC DENTAL LIGHT | A-Dec, Inc. | Jul 14, 1989 | SESE | | [K891216](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K891216.md) | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | Jun 2, 1989 | SESE | | [K884223](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K884223.md) | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | Mar 17, 1989 | SESE | | [K874374](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K874374.md) | THE WOOG ORATEST | Woog Intl. | Jan 19, 1988 | SESE | | [K863019](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K863019.md) | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | Sep 29, 1986 | SESE | | [K832919](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K832919.md) | OPTI-BEAM IV | Dentsply Intl. | Mar 2, 1984 | SESE | | [K801683](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K801683.md) | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | Aug 4, 1980 | SESE | | [K790984](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ/K790984.md) | KLIP-LITE | Innovators, Inc. | Oct 22, 1979 | SESE | ## Top Applicants - Trylon Corp. — 2 clearances - Addent, Inc. — 2 clearances - Woog Intl. — 1 clearance - Steri-Shield Products, Inc. — 1 clearance - Sds Dental, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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