EAY — Light, Fiber Optic, Dental Class I
FDA product code EAY covers "Light, Fiber Optic, Dental", a Class I medical device regulated under 21 CFR 872.4620. Submissions are reviewed by the Dental panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EAY
- Device Class
- Class I
- Regulation Number
- 872.4620
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K953191 | beaverstate dental | MODEL A15-101 | September 5, 1995 |
| K953192 | beaverstate dental | MODEL A15-103 | September 5, 1995 |
| K935718 | jedental co | JEDENTAL VLC DENTAL CURING LIGHT | January 26, 1994 |
| K871816 | stryker | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | August 3, 1987 |
| K831976 | ritter | POWER OPTIC | August 12, 1983 |
| K831824 | silverman | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | August 11, 1983 |
| K820907 | chayes virginia | DENTISCOPE | May 5, 1982 |
| K812605 | venture technology | FIBER OPTIC LIGHT SOURCE I | October 2, 1981 |
| K802684 | vivadent (usa) | HELIOMAT | November 24, 1980 |
| K802716 | den-mat | DEN-MAT FIBER OPTIC HALOGEN LIGHT | November 12, 1980 |
| K801591 | lares manufacturing co | FIBER OPTIC ILLUMINATOR | July 21, 1980 |
| K801592 | lares manufacturing co | FIBER OPTIC HOSE | July 21, 1980 |
| K791771 | midwest | ORALUMINATOR III AUTO-LIGHT | November 20, 1979 |
| K791733 | midwest | LIGHT-PAK | October 23, 1979 |
| K781878 | midwest | LIGHT, INSIDE | December 29, 1978 |
| K761331 | syntex | OPUS I OPTION - FIBER OPTIC L SYSTEM | January 3, 1977 |
| K760796 | midwest | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | October 20, 1976 |
| K760795 | midwest | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | October 20, 1976 |