Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4620](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4620) → EAY — Light, Fiber Optic, Dental # EAY · Light, Fiber Optic, Dental _Dental · 21 CFR 872.4620 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY ## Overview - **Product Code:** EAY - **Device Name:** Light, Fiber Optic, Dental - **Regulation:** [21 CFR 872.4620](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4620) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) ## Identification A fiber optic dental light is a device that is a light, usually AC-powered, that consists of glass or plastic fibers which have special optical properties. The device is usually attached to a dental handpiece and is intended to illuminate a patient's oral structures. ## 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 (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K953192](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K953192.md) | MODEL A15-103 | Beaverstate Dental, Inc. | Sep 5, 1995 | SESE | | [K953191](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K953191.md) | MODEL A15-101 | Beaverstate Dental, Inc. | Sep 5, 1995 | SESE | | [K935718](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K935718.md) | JEDENTAL VLC DENTAL CURING LIGHT | Jedental Co., Inc. | Jan 26, 1994 | SESE | | [K871816](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K871816.md) | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Stryker Corp. | Aug 3, 1987 | SESE | | [K831976](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K831976.md) | POWER OPTIC | Ritter Co. | Aug 12, 1983 | SESE | | [K831824](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K831824.md) | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S | Aug 11, 1983 | SESE | | [K820907](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K820907.md) | DENTISCOPE | Chayes Virginia, Inc. | May 5, 1982 | SESE | | [K812605](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K812605.md) | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. | Oct 2, 1981 | SESE | | [K802684](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K802684.md) | HELIOMAT | Vivadent (Usa), Inc. | Nov 24, 1980 | SESE | | [K802716](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K802716.md) | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Den-Mat Corp. | Nov 12, 1980 | SESE | | [K801592](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K801592.md) | FIBER OPTIC HOSE | Lares Manufacturing Co., Inc. | Jul 21, 1980 | SESE | | [K801591](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K801591.md) | FIBER OPTIC ILLUMINATOR | Lares Manufacturing Co., Inc. | Jul 21, 1980 | SESE | | [K791771](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K791771.md) | ORALUMINATOR III AUTO-LIGHT | Midwest | Nov 20, 1979 | SESE | | [K791733](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K791733.md) | LIGHT-PAK | Midwest | Oct 23, 1979 | SESE | | [K781878](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K781878.md) | LIGHT, INSIDE | Midwest | Dec 29, 1978 | SESE | | [K761331](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K761331.md) | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. | Jan 3, 1977 | SESE | | [K760796](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K760796.md) | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Midwest | Oct 20, 1976 | SESE | | [K760795](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY/K760795.md) | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Midwest | Oct 20, 1976 | SESE | ## Top Applicants - Midwest — 5 clearances - Beaverstate Dental, Inc. — 2 clearances - Lares Manufacturing Co., Inc. — 2 clearances - Chayes Virginia, Inc. — 1 clearance - Den-Mat Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EAY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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