EAZ · Light, Operating, Dental
Dental · 21 CFR 872.4630 · Class 1
Overview
| Product Code | EAZ |
|---|---|
| Device Name | Light, Operating, Dental |
| Regulation | 21 CFR 872.4630 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Cleared Devices (23)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072309 | MICROLUX/BLU | Addent, Inc. | Nov 19, 2007 | SESE |
| K041614 | MICROLUX DL | Addent, Inc. | Apr 4, 2005 | SESE |
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | Nov 22, 2004 | SESE |
| K003995 | SPECULITE/ORALLITE | Trylon Corp. | Mar 16, 2001 | SESE |
| K926081 | DENTAL LIGHT | Mdt Corp., Inc. | Jan 26, 1994 | SESE |
| K935390 | SIROLUX FANTASTIC | Pelton & Crane Co. | Dec 10, 1993 | SESE |
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | Nov 23, 1993 | SESE |
| K923462 | DELIGHT | Planmeca USA, Inc. | Dec 21, 1992 | SESE |
| K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | Oct 30, 1991 | SESE |
| K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | Oct 30, 1991 | SESE |
| K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | Sep 17, 1990 | SESE |
| K894059 | ISOLIGHT | Eurodent, Inc. | Sep 7, 1989 | SESE |
| K893044 | A-DEC DENTAL LIGHT | A-Dec, Inc. | Jul 14, 1989 | SESE |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | Jun 2, 1989 | SESE |
| K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | Mar 17, 1989 | SESE |
| K874374 | THE WOOG ORATEST | Woog Intl. | Jan 19, 1988 | SESE |
| K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | Sep 29, 1986 | SESE |
| K832919 | OPTI-BEAM IV | Dentsply Intl. | Mar 2, 1984 | SESE |
| K801683 | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | Aug 4, 1980 | SESE |
| K790984 | KLIP-LITE | Innovators, Inc. | Oct 22, 1979 | SESE |
| K772351 | DENTAL LIGHT | Chemetron Dental Products | Jan 17, 1978 | SESE |
| K771249 | JOY LIGHT | M.D. Intl., Inc. | Jul 15, 1977 | SESE |
| K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | Ritter Co. | Oct 5, 1976 | 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
