Product Code: EAZ FDA class 1 21 CFR 872.4630

Light, Operating, Dental

Dental

The Dental Operating Light is a high-intensity light fixture positioned over the dental chair to provide focused, shadow-free illumination of the patient's oral cavity during dental examination and treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAZ and the applicable regulation is 21 CFR 872.4630, under the Dental medical specialty.

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510(k)s

FEI Numbers

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Basic Information

Product Code: EAZ
Device Class: FDA class 1
Regulation Number: 872.4630
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K072309	MICROLUX/BLU	Nov 19, 2007	Substantially Equivalent	Addent, Inc.
K041614	MICROLUX DL	Apr 04, 2005	Substantially Equivalent	Addent, Inc.
K033033	VIZILITE-BLUE ORAL EXAM KIT	Nov 22, 2004	Substantially Equivalent	Trylon Corp.
K003995	SPECULITE/ORALLITE	Mar 16, 2001	Substantially Equivalent	Trylon Corp.
K926081	DENTAL LIGHT	Jan 26, 1994	Substantially Equivalent	Mdt Corp., Inc.
K935390	SIROLUX FANTASTIC	Dec 10, 1993	Substantially Equivalent	Pelton & Crane Co.
K925629	ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT	Nov 23, 1993	Substantially Equivalent	Den-Tal-Ez Mfg Co., Inc.
K923462	DELIGHT	Dec 21, 1992	Substantially Equivalent	Planmeca USA, Inc.
K912997	MINIFLEX AND PERSONAL UNIT	Oct 30, 1991	Substantially Equivalent	Dabi-Atlante America Corp.
K912142	MICRONAIRE ISO-HOOD MAX 5UV	Oct 30, 1991	Substantially Equivalent	Micronaire Corp.
K902685	DEFIANCE MODEL FUS 336	Sep 17, 1990	Substantially Equivalent	Defiance Electronics, Inc.
K894059	ISOLIGHT	Sep 07, 1989	Substantially Equivalent	Eurodent, Inc.
K893044	A-DEC DENTAL LIGHT	Jul 14, 1989	Substantially Equivalent	A-Dec, Inc.
K891216	DENTAL EQUIPMENT PROTECTION DEVICES	Jun 02, 1989	Substantially Equivalent	Pro-Safe Professional Linens, Inc.
K884223	DENTAL LAMP HANDLE COVER	Mar 17, 1989	Substantially Equivalent	Steri-Shield Products, Inc.
K874374	THE WOOG ORATEST	Jan 19, 1988	Substantially Equivalent	Woog Intl.
K863019	F-11 REFLECTOR / F-II STANDARD REFLECTOR	Sep 29, 1986	Substantially Equivalent	Sds Dental, Inc.
K832919	OPTI-BEAM IV	Mar 02, 1984	Substantially Equivalent	Dentsply Intl.
K801683	LUNA-VUE DENTAL OPERATING LIGHT	Aug 04, 1980	Substantially Equivalent	Pacific Dental Corp.
K790984	KLIP-LITE	Oct 22, 1979	Substantially Equivalent	Innovators, Inc.
K772351	DENTAL LIGHT	Jan 17, 1978	Substantially Equivalent	Chemetron Dental Products
K771249	JOY LIGHT	Jul 15, 1977	Substantially Equivalent	M.D. Intl., Inc.
K760707	RITTER STARLIGHT DENTAL OPERATING LIGHT	Oct 05, 1976	Substantially Equivalent	Ritter Co.