Product code EAZ
- Device name
- Light, Operating, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4630
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072309 | MICROLUX/BLU | Addent, Inc. | 2007-11-19 |
| K041614 | MICROLUX DL | Addent, Inc. | 2005-04-04 |
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | 2004-11-22 |
| K003995 | SPECULITE/ORALLITE | Trylon Corp. | 2001-03-16 |
| K926081 | DENTAL LIGHT | Mdt Corp., Inc. | 1994-01-26 |
| K935390 | SIROLUX FANTASTIC | Pelton & Crane Co. | 1993-12-10 |
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | 1993-11-23 |
| K923462 | DELIGHT | Planmeca USA, Inc. | 1992-12-21 |
| K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | 1991-10-30 |
| K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | 1991-10-30 |
| K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | 1990-09-17 |
| K894059 | ISOLIGHT | Eurodent, Inc. | 1989-09-07 |
| K893044 | A-DEC DENTAL LIGHT | A-Dec, Inc. | 1989-07-14 |
| K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | 1989-06-02 |
| K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | 1989-03-17 |
| K874374 | THE WOOG ORATEST | Woog Intl. | 1988-01-19 |
| K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | 1986-09-29 |
| K832919 | OPTI-BEAM IV | Dentsply Intl. | 1984-03-02 |
| K801683 | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | 1980-08-04 |
| K790984 | KLIP-LITE | Innovators, Inc. | 1979-10-22 |
| K772351 | DENTAL LIGHT | Chemetron Dental Products | 1978-01-17 |
| K771249 | JOY LIGHT | M.D. Intl., Inc. | 1977-07-15 |
| K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | Ritter Co. | 1976-10-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D0699073PINTG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074WTC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074WT0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074WG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074WC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074W0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074CTG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074CTC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074CT0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074CG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074CC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699074C0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073TG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073TC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073T0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| 10817417021781 | Aseptico | ASEPTICO, INC. | 2022-12-08 |
| D0699073PINTC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073PINT0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073PG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073PC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073P0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073INTG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073INTC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073INT0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073G0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073CLG0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073CLC0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073CL0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| D0699073C0 | Forest | Ls Enterprises, Inc. | 2022-12-08 |
| 10817417021798 | Aseptico | ASEPTICO, INC. | 2022-12-08 |