FDA product code EHA: Aligner, Beam, X-Ray
EHA is the FDA product code for aligner, beam, x-ray. It is a Class I device, regulated under 21 CFR 872.1820 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EHA. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Aligner, Beam, X-Ray |
| Device class | Class I |
| Regulation | 21 CFR 872.1820 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every EHA clearance
Top EHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Benn Research , Ltd. | 1 | 1989-04-12 |
Most recent EHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K891186 | Benn Research , Ltd. | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT | 1989-04-12 | 37 |
Recalls for EHA devices
openFDA lists no recalls for product code EHA.
Frequently asked questions
What is FDA product code EHA?
EHA is the FDA product code for aligner, beam, x-ray. It is a Class I device, regulated under 21 CFR 872.1820 and reviewed by the Dental panel.
What device class is EHA?
Class I, regulation 21 CFR 872.1820. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EHA?
Across 1 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most EHA clearances?
Benn Research , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code EHA
- Run a recall and safety report across every EHA manufacturer
- Watch product code EHA 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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