Light, Fiber Optic, Dental
The Dental Fiber Optic Light is a dental device that transmits high-intensity light via fiber optic cables to illuminate the oral cavity or to transilluminate teeth for detection of cracks and caries during 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 EAY and the applicable regulation is 21 CFR 872.4620, under the Dental medical specialty.
Basic Information
- Product Code
- EAY
- Device Class
- FDA class 1
- Regulation Number
- 872.4620
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953192 | MODEL A15-103 | Sep 05, 1995 | Substantially Equivalent | BEAVERSTATE DENTAL, INC. |
| K953191 | MODEL A15-101 | Sep 05, 1995 | Substantially Equivalent | BEAVERSTATE DENTAL, INC. |
| K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jan 26, 1994 | Substantially Equivalent | JEDENTAL CO., INC. |
| K871816 | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Aug 03, 1987 | Substantially Equivalent | STRYKER CORP. |
| K831976 | POWER OPTIC | Aug 12, 1983 | Substantially Equivalent | RITTER CO. |
| K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Aug 11, 1983 | Substantially Equivalent | SILVERMAN'S |
| K820907 | DENTISCOPE | May 05, 1982 | Substantially Equivalent | CHAYES VIRGINIA, INC. |
| K812605 | FIBER OPTIC LIGHT SOURCE I | Oct 02, 1981 | Substantially Equivalent | VENTURE TECHNOLOGY, INC. |
| K802684 | HELIOMAT | Nov 24, 1980 | Substantially Equivalent | VIVADENT (USA), INC. |
| K802716 | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Nov 12, 1980 | Substantially Equivalent | DEN-MAT CORP. |
| K801592 | FIBER OPTIC HOSE | Jul 21, 1980 | Substantially Equivalent | LARES MANUFACTURING CO., INC. |
| K801591 | FIBER OPTIC ILLUMINATOR | Jul 21, 1980 | Substantially Equivalent | LARES MANUFACTURING CO., INC. |
| K791771 | ORALUMINATOR III AUTO-LIGHT | Nov 20, 1979 | Substantially Equivalent | MIDWEST |
| K791733 | LIGHT-PAK | Oct 23, 1979 | Substantially Equivalent | MIDWEST |
| K781878 | LIGHT, INSIDE | Dec 29, 1978 | Substantially Equivalent | MIDWEST |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Jan 03, 1977 | Substantially Equivalent | SYNTEX CORP. |
| K760796 | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Oct 20, 1976 | Substantially Equivalent | MIDWEST |
| K760795 | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Oct 20, 1976 | Substantially Equivalent | MIDWEST |
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.