Product code EAY
- Device name
- Light, Fiber Optic, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4620
- 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 |
|---|---|---|---|
| K953192 | MODEL A15-103 | Beaverstate Dental, Inc. | 1995-09-05 |
| K953191 | MODEL A15-101 | Beaverstate Dental, Inc. | 1995-09-05 |
| K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jedental Co., Inc. | 1994-01-26 |
| K871816 | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Stryker Corp. | 1987-08-03 |
| K831976 | POWER OPTIC | Ritter Co. | 1983-08-12 |
| K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S | 1983-08-11 |
| K820907 | DENTISCOPE | Chayes Virginia, Inc. | 1982-05-05 |
| K812605 | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. | 1981-10-02 |
| K802684 | HELIOMAT | Vivadent (Usa), Inc. | 1980-11-24 |
| K802716 | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Den-Mat Corp. | 1980-11-12 |
| K801592 | FIBER OPTIC HOSE | Lares Manufacturing Co., Inc. | 1980-07-21 |
| K801591 | FIBER OPTIC ILLUMINATOR | Lares Manufacturing Co., Inc. | 1980-07-21 |
| K791771 | ORALUMINATOR III AUTO-LIGHT | Midwest | 1979-11-20 |
| K791733 | LIGHT-PAK | Midwest | 1979-10-23 |
| K781878 | LIGHT, INSIDE | Midwest | 1978-12-29 |
| K761331 | OPUS I OPTION - FIBER OPTIC L SYSTEM | Syntex Corp. | 1977-01-03 |
| K760795 | FIBER OPTICS DENTAL HOSE W/INTEGRAL L.C. | Midwest | 1976-10-20 |
| K760796 | ORALUMINATOR III - LIGHT SOURCE FOR F.O. | Midwest | 1976-10-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00814005021508 | 03BAT-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005022482 | 76R-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023120 | HDP | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023267 | LG316-7 | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023274 | LG316-8 | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023281 | LG316-9 | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023380 | MDP | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023403 | Minn-S | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023489 | PE-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005023748 | Seldin 23-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005024349 | HDP-02 | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005024363 | MR-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 00814005021485 | 03BA-FO | Quality Aspirators, Inc. | 2025-02-27 |
| 04719883751348 | APOZA | APOZA ENTERPRISE CO., LTD. | 2023-06-26 |
| 04719883751362 | APOZA | APOZA ENTERPRISE CO., LTD. | 2023-06-26 |
| 04719883751331 | APOZA | APOZA ENTERPRISE CO., LTD. | 2023-06-21 |
| 04719883751355 | APOZA | APOZA ENTERPRISE CO., LTD. | 2023-06-21 |
| D2483550861 | FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP | HAGER WORLDWIDE, INC. | 2023-05-12 |
| D2483550871 | FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIP | HAGER WORLDWIDE, INC. | 2023-05-12 |
| D2483550881 | FOCU-TIP NO.9 (SET/2) WHITE LIGHT INTENSIFYING TIP | HAGER WORLDWIDE, INC. | 2023-05-12 |
| D2483550891 | FOCU-TIP NO.12 (SET/2) WHITE LIGHT INTENSIFYING TIP | HAGER WORLDWIDE, INC. | 2023-05-12 |
| D836PSLFH9 | LED Curing Light | DENT ZAR, INC. | 2022-03-07 |
| 04560218680945 | DENTECH | DENTECH CORPORATION | 2020-09-24 |
| D798LEDBAT0 | LED Battery | RELIANCE ORTHODONTIC PRODUCTS INC | 2016-09-20 |
| 00889024133396 | NA | Zimmer, Inc. | 2016-07-25 |
| 00889024134317 | NA | Zimmer, Inc. | 2016-07-25 |
| 00889024134478 | NA | Zimmer, Inc. | 2016-07-25 |
| 00889024134485 | NA | Zimmer, Inc. | 2016-07-25 |
| 00889024134492 | NA | Zimmer, Inc. | 2016-07-25 |
| 00889024134508 | NA | Zimmer, Inc. | 2016-07-25 |