Product code EBA
- Device name
- Light, Surgical Headlight
- 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 |
|---|---|---|---|
| K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | 2007-02-12 |
| K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | 1992-10-16 |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | 1989-06-22 |
| K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | 1986-03-06 |
| K842515 | SURGICAL HEADLIGHT | Good-Lite Co. | 1984-08-02 |
| K842358 | ISOLIGHT | Planmeca USA, Inc. | 1984-07-31 |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | 1982-09-28 |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | 1981-02-10 |
| K790806 | PORCELIT | Harry J. Bosworth Co. | 1979-08-03 |
| K790807 | METALIT | Harry J. Bosworth Co. | 1979-08-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00615375008805 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009338 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009321 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009314 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009307 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009291 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009284 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009277 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009260 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009253 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009246 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008898 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008881 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008874 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008867 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008782 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008737 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008720 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008713 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008706 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008690 | Orascoptic - Endeavour XL Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000502 | Orascoptic - Spark Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000380 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000373 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000366 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000359 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375000342 | Orascoptic - Endeavour Headlight System | METREX RESEARCH, LLC | 2022-12-08 |
| M678HL0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| M678HLM0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| 00614950000074 | ACE | ACE SURGICAL SUPPLY CO., INC. | 2015-10-21 |