EAZ — Light, Operating, Dental Class I
FDA product code EAZ covers "Light, Operating, Dental", a Class I medical device regulated under 21 CFR 872.4630. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EAZ
- Device Class
- Class I
- Regulation Number
- 872.4630
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K072309 | addent | MICROLUX/BLU | November 19, 2007 |
| K041614 | addent | MICROLUX DL | April 4, 2005 |
| K033033 | trylon | VIZILITE-BLUE ORAL EXAM KIT | November 22, 2004 |
| K003995 | trylon | SPECULITE/ORALLITE | March 16, 2001 |
| K926081 | mdt corp | DENTAL LIGHT | January 26, 1994 |
| K935390 | pelton and crane | SIROLUX FANTASTIC | December 10, 1993 |
| K925629 | den-tal-ez mfg co | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | November 23, 1993 |
| K923462 | planmeca usa | DELIGHT | December 21, 1992 |
| K912142 | micronaire | MICRONAIRE ISO-HOOD MAX 5UV | October 30, 1991 |
| K912997 | dabi-atlante america | MINIFLEX AND PERSONAL UNIT | October 30, 1991 |
| K902685 | defiance electronics | DEFIANCE MODEL FUS 336 | September 17, 1990 |
| K894059 | eurodent | ISOLIGHT | September 7, 1989 |
| K893044 | a-dec | A-DEC DENTAL LIGHT | July 14, 1989 |
| K891216 | pro-safe professional linens | DENTAL EQUIPMENT PROTECTION DEVICES | June 2, 1989 |
| K884223 | steri-shield products | DENTAL LAMP HANDLE COVER | March 17, 1989 |
| K874374 | woog intl | THE WOOG ORATEST | January 19, 1988 |
| K863019 | sds dental | F-11 REFLECTOR / F-II STANDARD REFLECTOR | September 29, 1986 |
| K832919 | dentsply intl | OPTI-BEAM IV | March 2, 1984 |
| K801683 | pacific dental | LUNA-VUE DENTAL OPERATING LIGHT | August 4, 1980 |
| K790984 | innovators | KLIP-LITE | October 22, 1979 |