EAY · Light, Fiber Optic, Dental
Dental · 21 CFR 872.4620 · Class 1
Overview
| Product Code | EAY |
|---|---|
| Device Name | Light, Fiber Optic, Dental |
| Regulation | 21 CFR 872.4620 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953192 | MODEL A15-103 | Beaverstate Dental, Inc. | Sep 5, 1995 | SESE |
| K953191 | MODEL A15-101 | Beaverstate Dental, Inc. | Sep 5, 1995 | SESE |
| K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jedental Co., Inc. | Jan 26, 1994 | SESE |
| K871816 | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Stryker Corp. | Aug 3, 1987 | SESE |
| K831976 | POWER OPTIC | Ritter Co. | Aug 12, 1983 | SESE |
| K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S | Aug 11, 1983 | SESE |
| K820907 | DENTISCOPE | Chayes Virginia, Inc. | May 5, 1982 | SESE |
| K812605 | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. | Oct 2, 1981 | SESE |
| K802684 | HELIOMAT | Vivadent (Usa), Inc. | Nov 24, 1980 | SESE |
| K802716 | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Den-Mat Corp. | Nov 12, 1980 | SESE |
| K801592 | FIBER OPTIC HOSE | Lares Manufacturing Co., Inc. | Jul 21, 1980 | SESE |
| K801591 | FIBER OPTIC ILLUMINATOR | Lares Manufacturing Co., Inc. | Jul 21, 1980 | SESE |
| K791771 | ORALUMINATOR III AUTO-LIGHT | Midwest | Nov 20, 1979 | SESE |
| K791733 | LIGHT-PAK | Midwest | Oct 23, 1979 | SESE |
| K781878 | LIGHT, INSIDE | Midwest | Dec 29, 1978 | SESE |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. | Jan 3, 1977 | SESE |
| K760796 | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Midwest | Oct 20, 1976 | SESE |
| K760795 | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Midwest | Oct 20, 1976 | SESE |
Top Applicants
- Midwest — 5 clearances
- Lares Manufacturing Co., Inc. — 2 clearances
- Beaverstate Dental, Inc. — 2 clearances
- Vivadent (Usa), Inc. — 1 clearance
- Venture Technology, Inc. — 1 clearance
