FDA product code EBA: Light, Surgical Headlight
EBA is the FDA product code for light, surgical headlight. It is a Class I device, regulated under 21 CFR 872.4630 and reviewed by the Dental panel. FDA has cleared 10 510(k) submissions under EBA, from 9 different applicants. The average 510(k) review took 62 days (median 56). FDA has posted 5 recalls for EBA devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Light, Surgical Headlight |
| Device class | Class I |
| Regulation | 21 CFR 872.4630 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EBA clearance
Top EBA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harry J. Bosworth Co. | 2 | 1979-08-03 |
| Photonic Optische Gerate GmbH & Cokg | 1 | 2007-02-12 |
| Sylvan Medical Fiberoptics | 1 | 1992-10-16 |
| Cuda Products Co. | 1 | 1989-06-22 |
| Alpine Dental Equipment Co. | 1 | 1986-03-06 |
4 more applicants have EBA clearances. See the full list in Caduvo.
Most recent EBA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070287 | Photonic Optische Gerate GmbH & Cokg | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | 2007-02-12 | 14 |
| K923949 | Sylvan Medical Fiberoptics | SYLVAN DENTAL HEADLIGHT SYSTEM | 1992-10-16 | 72 |
| K893458 | Cuda Products Co. | FIBEROPTIC HEADLIGHT SYSTEM | 1989-06-22 | 51 |
| K854646 | Alpine Dental Equipment Co. | VEGA DENTAL OPERATING LIGHT | 1986-03-06 | 107 |
| K842515 | Good-Lite Co. | SURGICAL HEADLIGHT | 1984-08-02 | 51 |
Recalls for EBA devices
5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-07-03.
| Year | Recalls |
|---|---|
| 2025 | 4 |
Frequently asked questions
What is FDA product code EBA?
EBA is the FDA product code for light, surgical headlight. It is a Class I device, regulated under 21 CFR 872.4630 and reviewed by the Dental panel.
What device class is EBA?
Class I, regulation 21 CFR 872.4630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EBA?
Across 10 cleared submissions the average was 62 days from receipt to decision (median 56).
Which companies have the most EBA clearances?
Harry J. Bosworth Co. (2); Photonic Optische Gerate GmbH & Cokg (1); Sylvan Medical Fiberoptics (1); Cuda Products Co. (1); Alpine Dental Equipment Co. (1).
Have EBA devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2025-07-03.
Next steps
- Run an FDA pathway report with predicate devices for product code EBA
- Run a recall and safety report across every EBA manufacturer
- Watch product code EBA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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